Trial Outcomes & Findings for Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis (NCT NCT03624127)

Last Updated: 2023-01-30

Results Overview

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

666 participants

Primary outcome timeframe

Week 16

Results posted on

2023-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	BMS-986165 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Pre-treatment STARTED	332	166	168
Pre-treatment COMPLETED	332	165	168
Pre-treatment NOT COMPLETED	0	1	0
Treatment Week 0 - Week 16 STARTED	332	165	168
Treatment Week 0 - Week 16 COMPLETED	307	145	145
Treatment Week 0 - Week 16 NOT COMPLETED	25	20	23
Treatment Week 16 - Week 24 STARTED	452	0	145
Treatment Week 16 - Week 24 COMPLETED	442	0	141
Treatment Week 16 - Week 24 NOT COMPLETED	10	0	4
Treatment Week 24 - Week 52 STARTED	496	0	87
Treatment Week 24 - Week 52 COMPLETED	444	0	83
Treatment Week 24 - Week 52 NOT COMPLETED	52	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	BMS-986165 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Pre-treatment Participant discontinued from study prior to treatment due to incorrect randomization	0	1	0
Treatment Week 0 - Week 16 Adverse Event	5	7	10
Treatment Week 0 - Week 16 Death	0	1	0
Treatment Week 0 - Week 16 Lack of Efficacy	0	1	1
Treatment Week 0 - Week 16 Lost to Follow-up	7	2	4
Treatment Week 0 - Week 16 Protocol Violation	1	1	2
Treatment Week 0 - Week 16 Withdrawal by Subject	4	3	3
Treatment Week 0 - Week 16 Other reasons	8	5	3
Treatment Week 16 - Week 24 Adverse Event	1	0	1
Treatment Week 16 - Week 24 Lack of Efficacy	3	0	0
Treatment Week 16 - Week 24 Lost to Follow-up	0	0	2
Treatment Week 16 - Week 24 Protocol Violation	1	0	0
Treatment Week 16 - Week 24 Withdrawal by Subject	2	0	1
Treatment Week 16 - Week 24 Other reasons	3	0	0
Treatment Week 24 - Week 52 Adverse Event	8	0	1
Treatment Week 24 - Week 52 Lack of Efficacy	6	0	0
Treatment Week 24 - Week 52 Lost to Follow-up	5	0	1
Treatment Week 24 - Week 52 Protocol Violation	2	0	0
Treatment Week 24 - Week 52 Site terminated by sponsor	2	0	0
Treatment Week 24 - Week 52 Withdrawal by Subject	10	0	0
Treatment Week 24 - Week 52 Other reasons	19	0	2

Baseline Characteristics

Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=166 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast n=168 Participants Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52	Total n=666 Participants Total of all reporting groups
Age, Continuous	45.9 Years STANDARD_DEVIATION 13.71 • n=5 Participants	47.9 Years STANDARD_DEVIATION 13.98 • n=7 Participants	44.7 Years STANDARD_DEVIATION 12.06 • n=5 Participants	46.1 Years STANDARD_DEVIATION 13.41 • n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	53 Participants n=7 Participants	58 Participants n=5 Participants	213 Participants n=4 Participants
Sex: Female, Male Male	230 Participants n=5 Participants	113 Participants n=7 Participants	110 Participants n=5 Participants	453 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants	26 Participants n=7 Participants	30 Participants n=5 Participants	106 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	282 Participants n=5 Participants	140 Participants n=7 Participants	138 Participants n=5 Participants	560 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	267 Participants n=5 Participants	128 Participants n=7 Participants	139 Participants n=5 Participants	534 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Asian	59 Participants n=5 Participants	34 Participants n=7 Participants	28 Participants n=5 Participants	121 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All randomized participants in BMS-986165 and Placebo arms

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=166 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	178 Participants	12 Participants	—

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants in BMS-986165 and Placebo arms

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=166 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	194 Participants	21 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=166 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast n=168 Participants Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90)	118 Participants	7 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Pre-specified for data to be collected only in all randomized from BMS-986165 and Placebo Arms

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=166 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100)	47 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=166 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast n=168 Participants Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0)	58 Participants	1 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Pre-specified for data to be collected only in all responders from BMS-986165 and Apremilast Arms

PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores, where 0 representing the least severe symptom/sign and 100 the most severe. A mBOCF approach will be used for missing data. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=306 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=158 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16	-29.4 Score on a scale Standard Deviation 24.43	-22.8 Score on a scale Standard Deviation 23.40	—

SECONDARY outcome

Timeframe: Week 16

Population: All Responders with a baseline PSSD symptom score \>= 1

PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score \>= 1.

Outcome measures

Outcome measures
Measure	BMS-986165 n=305 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=149 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast n=158 Participants Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16	24 Participants	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Pre-specified for data to be collected only in all responders with a baseline DLQI score \>=2 from BMS-986165 and Placebo Arms

DLQI is a participant-reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (0 = "not at all"; 1 = "a little"; 2 = "a lot"; or 3 = "very much"). The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score \>=2.

Outcome measures

Outcome measures
Measure	BMS-986165 n=322 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=160 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)	132 Participants	17 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: Pre-specified for data to be collected only in all responders with a baseline PGA-F score \>=3 from BMS-986165 and Placebo Arms

PGA-F overall condition of the fingernails is rated on a 5-point scale (0 = clear; 1 = minimal; 2 = mild; 3 = moderate; and 4 = severe). PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score \>=3.

Outcome measures

Outcome measures
Measure	BMS-986165 n=43 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=34 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16	9 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants in BMS-986165 and Apremilast arms

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=168 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)	194 Participants	59 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in BMS-986165 and Apremilast arms

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=168 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)	178 Participants	54 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: All responders with a baseline ss-PGA score \>=3

ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (0 = absence of disease; 1 = very mild disease; 2 = mild disease; 3 = moderate disease; 4 = severe disease). ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score \>=3.

Outcome measures

Outcome measures
Measure	BMS-986165 n=209 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=121 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast n=110 Participants Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)	147 Participants	21 Participants	43 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Pre-specified for data to be collected in all randomized who received BMS-986165 only and Apremilast

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=168 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1)	195 Participants	52 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Pre-specified for data to be collected in all randomized who received BMS-986165 only and Apremilast

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=168 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 75)	230 Participants	64 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Pre-specified for data to be collected in all randomized who received BMS-986165 only and Apremilast

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=168 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)	140 Participants	37 Participants	—

SECONDARY outcome

Timeframe: Week 52 and Week 24

Population: Pre-specified for data to be collected in all responders treated in BMS-986165 arm and Apremilast arm

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=167 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1)	151 Participants	37 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Week 24

Population: Pre-specified for data to be collected in all responders treated in BMS-986165 arm and Apremilast arm

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=167 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 75)	187 Participants	51 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Week 24

Population: Pre-specified for data to be collected in all responders treated in BMS-986165 arm and Apremilast arm

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Outcome measures

Outcome measures
Measure	BMS-986165 n=332 Participants BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast	Placebo n=167 Participants Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52	Apremilast Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90)	103 Participants	26 Participants	—

Adverse Events

BMS-986165 Week 0 up to Week 16

Serious events: 7 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo Week 0 up to Week 16

Serious events: 9 serious events

Other events: 24 other events

Deaths: 1 deaths

Apremilast Week 0 up to Week 16

Serious events: 4 serious events

Other events: 60 other events

Deaths: 0 deaths

BMS-986165 Week 0 up to Week 52

Serious events: 31 serious events

Other events: 197 other events

Deaths: 0 deaths

Placebo Week 0 up to Week 52

Serious events: 9 serious events

Other events: 24 other events

Deaths: 1 deaths

Apremilast Week 0 up to Week 52

Serious events: 6 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BMS-986165 Week 0 up to Week 16 n=332 participants at risk BMS-986165 6 mg daily (QD) week 0 - week 16	Placebo Week 0 up to Week 16 n=165 participants at risk Participants received placebo week 0 - week 16	Apremilast Week 0 up to Week 16 n=168 participants at risk Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 16	BMS-986165 Week 0 up to Week 52 n=531 participants at risk BMS-986165 6 mg daily (QD) week 0 - week 52	Placebo Week 0 up to Week 52 n=165 participants at risk Participants received placebo week 0 - week 52	Apremilast Week 0 up to Week 52 n=168 participants at risk Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 52
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Acute myocardial infarction	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Angina unstable	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial fibrillation	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Hypertensive heart disease	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Myocardial infarction	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Pericarditis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.38% 2/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Supraventricular tachycardia	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Ventricular tachycardia	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Cataract	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Small intestinal perforation	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Hernia perforation	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Incarcerated hernia	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholecystitis acute	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.38% 2/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholelithiasis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19 pneumonia	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Carbuncle	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Diverticulitis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Infectious mononucleosis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Localised infection	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pharyngotonsillitis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pilonidal cyst	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pyelonephritis	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Hand fracture	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Tendon injury	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Toxicity to various agents	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Ischaemic stroke	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.60% 1/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Status epilepticus	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Transient ischaemic attack	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Stress urinary incontinence	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Ureterolithiasis	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.30% 1/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.61% 1/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Aortic dissection	0.00% 0/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.19% 1/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Other adverse events
Measure	BMS-986165 Week 0 up to Week 16 n=332 participants at risk BMS-986165 6 mg daily (QD) week 0 - week 16	Placebo Week 0 up to Week 16 n=165 participants at risk Participants received placebo week 0 - week 16	Apremilast Week 0 up to Week 16 n=168 participants at risk Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 16	BMS-986165 Week 0 up to Week 52 n=531 participants at risk BMS-986165 6 mg daily (QD) week 0 - week 52	Placebo Week 0 up to Week 52 n=165 participants at risk Participants received placebo week 0 - week 52	Apremilast Week 0 up to Week 52 n=168 participants at risk Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 52
Gastrointestinal disorders Diarrhoea	3.9% 13/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 6/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	10.1% 17/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 30/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 6/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	11.3% 19/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	2.1% 7/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 4/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	11.3% 19/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	1.3% 7/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 4/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 21/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Nasopharyngitis	6.3% 21/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	4.2% 7/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 14/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	18.1% 96/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	4.2% 7/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	15.5% 26/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	6.3% 21/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 6/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 3/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	9.4% 50/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 6/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 6/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	4.8% 16/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.0% 5/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	10.1% 17/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 35/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.0% 5/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	13.7% 23/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	1.8% 6/332 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 6/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	2.6% 14/531 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/165 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 9/168 • Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other 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: [email protected]

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