Trial Outcomes & Findings for An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease (NCT NCT03599622)

NCT ID: NCT03599622

Last Updated: 2024-07-03

Results Overview

Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 239 participants
• Primary outcome timeframe: 12 weeks after first dose
• Results posted on: 2024-07-03

Participant Flow

This study has a treat-through design

Enrollment into the 12 mg BMS-986165 arm was discontinued. Participants who were randomized to 12 mg BMS-986165 continued on their originally assigned double-blind study treatment. These participants completed all study procedures and assessments outlined in the current version of the protocol.

Participant milestones

Measure	Placebo Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Pre-Treatment Period STARTED	60	86	84	9
Pre-Treatment Period COMPLETED	59	84	83	9
Pre-Treatment Period NOT COMPLETED	1	2	1	0
Treatment Period STARTED	59	84	83	9
Treatment Period COMPLETED	13	14	14	4
Treatment Period NOT COMPLETED	46	70	69	5

Reasons for withdrawal

Measure	Placebo Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Pre-Treatment Period Withdrawal by Subject	0	1	0	0
Pre-Treatment Period Other reasons	1	1	1	0
Treatment Period Adverse Event	11	20	18	2
Treatment Period Lack of Efficacy	18	12	13	2
Treatment Period Withdrawal by Subject	5	11	16	1
Treatment Period Other reasons	4	6	7	0
Treatment Period Lost to Follow-up	1	0	0	0
Treatment Period Study terminated by sponsor	7	20	15	0
Treatment Period Site terminated by sponsor	0	1	0	0

Baseline Characteristics

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Measure	Placebo n=60 Participants Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=86 Participants BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=84 Participants BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 Participants BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	Total n=239 Participants Total of all reporting groups
Age, Continuous	39.1 Years STANDARD_DEVIATION 16.7 • n=5 Participants	39.5 Years STANDARD_DEVIATION 15.2 • n=7 Participants	37.9 Years STANDARD_DEVIATION 14.6 • n=5 Participants	37.4 Years STANDARD_DEVIATION 13.7 • n=4 Participants	38.8 Years STANDARD_DEVIATION 15.3 • n=21 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	38 Participants n=7 Participants	34 Participants n=5 Participants	3 Participants n=4 Participants	97 Participants n=21 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	48 Participants n=7 Participants	50 Participants n=5 Participants	6 Participants n=4 Participants	142 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants	78 Participants n=7 Participants	80 Participants n=5 Participants	9 Participants n=4 Participants	225 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	1 Participants n=4 Participants	37 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized White	48 Participants n=5 Participants	70 Participants n=7 Participants	68 Participants n=5 Participants	8 Participants n=4 Participants	194 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks after first dose

Population: All randomized participants.

Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

Outcome measures

Measure	Placebo n=60 Participants Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=86 Participants BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=84 Participants BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 Participants BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Percent of Participants Achieving Clinical Remission at Week 12	28.3 Percent of Participants Interval 16.9 to 39.7	32.6 Percent of Participants Interval 22.7 to 42.5	21.4 Percent of Participants Interval 12.7 to 30.2	22.2 Percent of Participants Interval 0.0 to 49.4

PRIMARY outcome

Timeframe: 12 weeks after first dose

Population: All randomized participants.

Endoscopic Response is defined as >= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

Outcome measures

Measure	Placebo n=60 Participants Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=86 Participants BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=84 Participants BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 Participants BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Percent of Participants Achieving Endoscopic Response at Week 12	8.3 Percent of Participants Interval 1.3 to 15.3	23.3 Percent of Participants Interval 14.3 to 32.2	16.7 Percent of Participants Interval 8.7 to 24.6	33.3 Percent of Participants Interval 2.5 to 64.1

SECONDARY outcome

Timeframe: 12 weeks after first dose

Population: All randomized participants.

Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score < 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

Outcome measures

Measure	Placebo n=60 Participants Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=86 Participants BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=84 Participants BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 Participants BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Percent of Participants Achieving Clinical Response at Week 12	40.0 Percent of Participants Interval 27.6 to 52.4	47.7 Percent of Participants Interval 37.1 to 58.2	38.1 Percent of Participants Interval 27.7 to 48.5	55.6 Percent of Participants Interval 23.1 to 88.0

SECONDARY outcome

Timeframe: 12 weeks after first dose

Population: All randomized participants.

The Patient Reported Outcomes 2 (PRO2) is a way for patients to report how they're feeling. It focuses on two things: how often they have loose or liquid stools, and how much abdominal pain they have. They keep track of these things every day for a week. Stool frequency is rated on a scale from 0 to 3, with 0 being the normal number of stools per day to 3 which is >/=5 stools more than normal per day. The pain is rated on a scale from 0 to 3, with 0 being no pain and 3 being severe pain. The scores for these two things are added up to get a total score ranging from 0-6. If the average daily score for abdominal pain is 1 or less, and the average number of loose or liquid stools is 3 or less, then the disease might be in remission.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

Outcome measures

Measure	Placebo n=60 Participants Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=86 Participants BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=84 Participants BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 Participants BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12	25.0 Percent of Participants Interval 14.0 to 36.0	32.6 Percent of Participants Interval 22.7 to 42.5	20.2 Percent of Participants Interval 11.6 to 28.8	33.3 Percent of Participants Interval 2.5 to 64.1

SECONDARY outcome

Timeframe: 12 weeks after first dose

Population: All randomized participants with available baseline and week 12 SES-CD scores.

The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants starting study treatment.

Outcome measures

Measure	Placebo n=50 Participants Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=70 Participants BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=58 Participants BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=7 Participants BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12	-1.5 Change in Score on a Scale Standard Deviation 4.3	-2.5 Change in Score on a Scale Standard Deviation 6.5	-3.7 Change in Score on a Scale Standard Deviation 5.5	-5.6 Change in Score on a Scale Standard Deviation 8.5

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 33 other events

Deaths: 0 deaths

3 mg BMS-986165

Serious events: 11 serious events

Other events: 55 other events

Deaths: 0 deaths

6 mg BMS-986165

Serious events: 5 serious events

Other events: 55 other events

Deaths: 0 deaths

12 mg BMS-986165

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

6 mg BMS-986165 - Open Label

Serious events: 15 serious events

Other events: 86 other events

Deaths: 0 deaths

12 mg BMS-986165 - Open Label

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=59 participants at risk Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=84 participants at risk BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=83 participants at risk BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 participants at risk BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	6 mg BMS-986165 - Open Label n=161 participants at risk Participants from the Placebo, 3 mg BMS-986165, and 6 mg BMS-986165 arms who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986164 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to begin/continue to receive BMS986165 6 mg twice daily. Participants who were randomized to the 12 mg BMS-986165 arm prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders from this arm who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	12 mg BMS-986165 - Open Label n=6 participants at risk Participants who took 12 mg BMS-986165 up to week 12/52 who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986164 12 mg once per day until week 104.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Crohn's disease	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.7% 6/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enteritis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Ileal perforation	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis necrotising	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Subileus	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Abdominal abscess	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Anal abscess	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Breast abscess	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Diabetic foot infection	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Infectious pleural effusion	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Lung abscess	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Mediastinitis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Norovirus infection	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Peritonsillar abscess	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urosepsis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Craniofacial injury	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Depression	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Haematoma	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Other adverse events

Measure	Placebo n=59 participants at risk Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	3 mg BMS-986165 n=84 participants at risk BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	6 mg BMS-986165 n=83 participants at risk BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	12 mg BMS-986165 n=9 participants at risk BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	6 mg BMS-986165 - Open Label n=161 participants at risk Participants from the Placebo, 3 mg BMS-986165, and 6 mg BMS-986165 arms who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986164 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to begin/continue to receive BMS986165 6 mg twice daily. Participants who were randomized to the 12 mg BMS-986165 arm prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders from this arm who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	12 mg BMS-986165 - Open Label n=6 participants at risk Participants who took 12 mg BMS-986165 up to week 12/52 who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986164 12 mg once per day until week 104.
Blood and lymphatic system disorders Anaemia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 4/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 2/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Ventricular extrasystoles	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.1% 6/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.4% 7/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 10/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Aphthous ulcer	3.4% 2/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.6% 3/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.6% 8/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 7/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Crohn's disease	15.3% 9/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.9% 10/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.0% 10/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.6% 17/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 2/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Mouth ulceration	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.1% 6/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 4/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 7/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	6.8% 4/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 4/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 5/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Proctalgia	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 2/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	8.5% 5/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 2/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.9% 3/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	6.8% 4/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 4/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.4% 7/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.6% 9/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations COVID-19	10.2% 6/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 11/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.7% 22/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Folliculitis	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.1% 6/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.5% 12/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	3.4% 2/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.7% 9/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 3/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.8% 11/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 5/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.2% 6/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.0% 8/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	5.1% 3/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 5/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.8% 4/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Headache	6.8% 4/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.1% 6/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.5% 4/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Reproductive system and breast disorders Breast haematoma	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.6% 3/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.6% 3/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.7% 1/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.8% 4/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 2/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.2% 6/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.5% 4/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Acne	3.4% 2/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.7% 9/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.5% 12/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 5/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	3.4% 2/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 5/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.7% 6/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/59 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/84 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.2% 1/83 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 1/9 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.62% 1/161 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/6 • Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months). All-Cause Mortality represents all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.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