Trial Outcomes & Findings for A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment (NCT NCT04908189)
NCT ID: NCT04908189
Last Updated: 2025-06-13
Results Overview
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
729 participants
Primary outcome timeframe
Week 16
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
Deucravacitinib
Deucravacitinib 6 mg daily
|
Placebo
Placebo daily
|
Apremilast
Apremilast 30 mg twice daily
|
|---|---|---|---|
|
Pre-treatment
STARTED
|
312
|
312
|
105
|
|
Pre-treatment
COMPLETED
|
312
|
311
|
105
|
|
Pre-treatment
NOT COMPLETED
|
0
|
1
|
0
|
|
Placebo-Controlled (Week 0 - Week 16)
STARTED
|
312
|
311
|
105
|
|
Placebo-Controlled (Week 0 - Week 16)
COMPLETED
|
292
|
292
|
90
|
|
Placebo-Controlled (Week 0 - Week 16)
NOT COMPLETED
|
20
|
19
|
15
|
|
Active Treatment (Week 16 - Week 52)
STARTED
|
292
|
292
|
90
|
|
Active Treatment (Week 16 - Week 52)
Participants Switched to Deucravacitinib
|
0
|
292
|
0
|
|
Active Treatment (Week 16 - Week 52)
COMPLETED
|
266
|
269
|
79
|
|
Active Treatment (Week 16 - Week 52)
NOT COMPLETED
|
26
|
23
|
11
|
Reasons for withdrawal
| Measure |
Deucravacitinib
Deucravacitinib 6 mg daily
|
Placebo
Placebo daily
|
Apremilast
Apremilast 30 mg twice daily
|
|---|---|---|---|
|
Placebo-Controlled (Week 0 - Week 16)
Lack of Efficacy
|
1
|
3
|
0
|
|
Placebo-Controlled (Week 0 - Week 16)
Adverse Event
|
6
|
4
|
10
|
|
Placebo-Controlled (Week 0 - Week 16)
Participant request to discontinue study treatment
|
2
|
4
|
2
|
|
Placebo-Controlled (Week 0 - Week 16)
Withdrawal by Subject
|
6
|
8
|
3
|
|
Placebo-Controlled (Week 0 - Week 16)
Administrative reason by sponsor
|
3
|
0
|
0
|
|
Placebo-Controlled (Week 0 - Week 16)
Other reasons
|
2
|
0
|
0
|
|
Active Treatment (Week 16 - Week 52)
Lack of Efficacy
|
6
|
6
|
1
|
|
Active Treatment (Week 16 - Week 52)
Adverse Event
|
9
|
7
|
3
|
|
Active Treatment (Week 16 - Week 52)
Participant request to discontinue study treatment
|
3
|
3
|
4
|
|
Active Treatment (Week 16 - Week 52)
Withdrawal by Subject
|
5
|
5
|
2
|
|
Active Treatment (Week 16 - Week 52)
Lost to Follow-up
|
2
|
1
|
0
|
|
Active Treatment (Week 16 - Week 52)
Other reasons
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Baseline characteristics by cohort
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
Apremilast
n=105 Participants
Apremilast 30 mg twice daily
|
Total
n=729 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.7 Years
STANDARD_DEVIATION 11.73 • n=93 Participants
|
49.3 Years
STANDARD_DEVIATION 12.18 • n=4 Participants
|
49.1 Years
STANDARD_DEVIATION 13.47 • n=27 Participants
|
49.0 Years
STANDARD_DEVIATION 12.17 • n=483 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=93 Participants
|
168 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
377 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
352 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
120 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=93 Participants
|
200 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
459 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
63 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
150 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
54 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
127 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
223 Participants
n=93 Participants
|
240 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
528 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
|
169 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=300 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=299 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
|
-1.3133 score on a scale
Standard Deviation 1.17420
|
-0.9095 score on a scale
Standard Deviation 1.10470
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=307 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=311 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
|
-0.3103 score on a scale
Standard Deviation 0.46159
|
-0.2219 score on a scale
Standard Deviation 0.46858
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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 number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=154 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=149 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
|
63 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=307 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=310 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
|
6.194 Score on a scale
Standard Deviation 7.4640
|
4.262 Score on a scale
Standard Deviation 7.0328
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Outcome measures
| Measure |
Deucravacitinib
n=140 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=150 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
|
74 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count ≤ 1 2. Swollen joint count ≤ 1 3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15 5. Patient Global Assessment of PsA disease activity ≤ 20 6. HAQ-DI ≤ 0.5 7. Tender enthesial points ≤ 1
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
|
80 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=307 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=310 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
|
2.6 Score on a scale
Standard Deviation 8.17
|
1.9 Score on a scale
Standard Deviation 8.54
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Outcome measures
| Measure |
Deucravacitinib
n=78 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=80 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Dactylitis Resolution at Week 16
|
43 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
|
90 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
|
33 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=309 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=311 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 2
|
-0.0546 score on a scale
Standard Deviation 0.38637
|
-0.1335 score on a scale
Standard Deviation 0.34583
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 4
|
-0.1547 score on a scale
Standard Deviation 0.41308
|
-0.1760 score on a scale
Standard Deviation 0.40042
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 8
|
-0.2301 score on a scale
Standard Deviation 0.44365
|
-0.1964 score on a scale
Standard Deviation 0.43603
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 12
|
-0.2544 score on a scale
Standard Deviation 0.45565
|
-0.2236 score on a scale
Standard Deviation 0.46098
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 16
|
-0.3103 score on a scale
Standard Deviation 0.46159
|
-0.2219 score on a scale
Standard Deviation 0.46858
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
Number of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline. HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered.
Outcome measures
| Measure |
Deucravacitinib
n=268 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=273 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
|
131 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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 number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=154 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=149 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
Week 12
|
45 Participants
|
22 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
Week 16
|
63 Participants
|
23 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
Week 4
|
14 Participants
|
10 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
Week 8
|
26 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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 number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=154 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=149 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
Week 4
|
4 Participants
|
3 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
Week 8
|
10 Participants
|
7 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
Week 12
|
31 Participants
|
15 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
Week 16
|
41 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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 number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Deucravacitinib
n=154 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=149 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
Week 4
|
2 Participants
|
0 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
Week 8
|
6 Participants
|
3 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
Week 12
|
17 Participants
|
9 Participants
|
|
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
Week 16
|
24 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=308 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=310 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
Week 4
|
3.364 Score on a scale
Standard Deviation 5.8439
|
2.771 Score on a scale
Standard Deviation 5.8897
|
|
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
Week 12
|
5.419 Score on a scale
Standard Deviation 7.1066
|
3.578 Score on a scale
Standard Deviation 6.7537
|
|
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
Week 16
|
6.194 Score on a scale
Standard Deviation 7.4640
|
4.262 Score on a scale
Standard Deviation 7.0328
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Outcome measures
| Measure |
Deucravacitinib
n=140 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=150 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Week 4
|
45 Participants
|
55 Participants
|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Week 8
|
70 Participants
|
54 Participants
|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Week 12
|
74 Participants
|
58 Participants
|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Week 16
|
74 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by SPARCC
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right \[R\]/left \[L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
Outcome measures
| Measure |
Deucravacitinib
n=177 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=196 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Week 8
|
73 Participants
|
55 Participants
|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Week 4
|
53 Participants
|
55 Participants
|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Week 12
|
75 Participants
|
66 Participants
|
|
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Week 16
|
86 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count ≤ 1 2. Swollen joint count ≤ 1 3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15 5. Patient Global Assessment of PsA disease activity ≤ 20 6. HAQ-DI ≤ 0.5 7. Tender enthesial points ≤ 1
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Week 4
|
19 Participants
|
16 Participants
|
|
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Week 8
|
35 Participants
|
28 Participants
|
|
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Week 12
|
56 Participants
|
24 Participants
|
|
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Week 16
|
80 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 MCS baseline and post-baseline measurements
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=308 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=310 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
Week 4
|
0.195 Score on a scale
Standard Deviation 7.7026
|
0.300 Score on a scale
Standard Deviation 7.7067
|
|
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
Week 12
|
1.245 Score on a scale
Standard Deviation 8.6442
|
0.123 Score on a scale
Standard Deviation 9.1804
|
|
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
Week 16
|
1.009 Score on a scale
Standard Deviation 9.7740
|
-0.438 Score on a scale
Standard Deviation 9.3388
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=309 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=310 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Week 2
|
0.8 Score on a scale
Standard Deviation 6.60
|
1.5 Score on a scale
Standard Deviation 6.52
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Week 4
|
1.3 Score on a scale
Standard Deviation 6.70
|
1.6 Score on a scale
Standard Deviation 6.95
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Week 8
|
2.9 Score on a scale
Standard Deviation 7.53
|
1.9 Score on a scale
Standard Deviation 8.54
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Week 12
|
2.2 Score on a scale
Standard Deviation 8.40
|
2.0 Score on a scale
Standard Deviation 8.91
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Week 16
|
2.6 Score on a scale
Standard Deviation 8.17
|
1.9 Score on a scale
Standard Deviation 8.54
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Outcome measures
| Measure |
Deucravacitinib
n=78 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=80 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Dactylitis Resolution
Week 4
|
24 Participants
|
30 Participants
|
|
Number of Participants Meeting Dactylitis Resolution
Week 8
|
31 Participants
|
27 Participants
|
|
Number of Participants Meeting Dactylitis Resolution
Week 12
|
39 Participants
|
29 Participants
|
|
Number of Participants Meeting Dactylitis Resolution
Week 16
|
43 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=309 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=310 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Week 2
|
-0.658 Score on a scale
Standard Deviation 1.3895
|
-0.590 Score on a scale
Standard Deviation 1.2369
|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Week 4
|
-0.986 Score on a scale
Standard Deviation 1.5902
|
-0.761 Score on a scale
Standard Deviation 1.5206
|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Week 8
|
-1.419 Score on a scale
Standard Deviation 1.7445
|
-0.849 Score on a scale
Standard Deviation 1.8018
|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Week 12
|
-1.511 Score on a scale
Standard Deviation 1.9314
|
-0.937 Score on a scale
Standard Deviation 1.9126
|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Week 16
|
-1.729 Score on a scale
Standard Deviation 2.0150
|
-0.968 Score on a scale
Standard Deviation 1.9075
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAPSA baseline and post-baseline measurements
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=308 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=307 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Week 2
|
-4.9619 Score on a scale
Standard Deviation 12.27319
|
-5.9569 Score on a scale
Standard Deviation 12.24097
|
|
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Week 4
|
-9.0129 Score on a scale
Standard Deviation 11.93271
|
-8.2813 Score on a scale
Standard Deviation 12.79788
|
|
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Week 8
|
-13.5855 Score on a scale
Standard Deviation 14.33402
|
-10.7292 Score on a scale
Standard Deviation 16.10715
|
|
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Week 12
|
-15.7385 Score on a scale
Standard Deviation 16.02197
|
-11.8980 Score on a scale
Standard Deviation 16.33187
|
|
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Week 16
|
-17.5225 Score on a scale
Standard Deviation 16.66002
|
-12.1547 Score on a scale
Standard Deviation 17.74566
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Week 2
|
25 Participants
|
18 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Week 4
|
44 Participants
|
42 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Week 8
|
69 Participants
|
55 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Week 12
|
95 Participants
|
66 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Week 16
|
104 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Week 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Week 4
|
2 Participants
|
1 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Week 8
|
12 Participants
|
4 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Week 12
|
20 Participants
|
8 Participants
|
|
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Week 16
|
30 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with a baseline PGA-F score of \>= 3
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
Deucravacitinib
n=51 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=45 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
Week 4
|
10 Participants
|
10 Participants
|
|
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
Week 8
|
13 Participants
|
13 Participants
|
|
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
Week 12
|
16 Participants
|
11 Participants
|
|
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
Week 16
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=308 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=307 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Week 2
|
-0.3226 Score on a scale
Standard Deviation 0.74392
|
-0.4044 Score on a scale
Standard Deviation 0.70334
|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Week 4
|
-0.6292 Score on a scale
Standard Deviation 0.84069
|
-0.5888 Score on a scale
Standard Deviation 0.75652
|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Week 8
|
-0.9992 Score on a scale
Standard Deviation 1.01750
|
-0.7579 Score on a scale
Standard Deviation 0.99991
|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Week 12
|
-1.1279 Score on a scale
Standard Deviation 1.14379
|
-0.8826 Score on a scale
Standard Deviation 1.03604
|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Week 16
|
-1.3133 Score on a scale
Standard Deviation 1.17420
|
-0.9095 Score on a scale
Standard Deviation 1.10470
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Week 2
|
23 Participants
|
19 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Week 4
|
39 Participants
|
31 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Week 8
|
35 Participants
|
32 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Week 12
|
54 Participants
|
39 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Week 16
|
56 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity.
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Week 2
|
13 Participants
|
7 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Week 4
|
27 Participants
|
14 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Week 8
|
57 Participants
|
31 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Week 12
|
64 Participants
|
35 Participants
|
|
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Week 16
|
84 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PASDAS baseline and post-baseline measurements
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=306 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=305 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Week 4
|
-0.8037 Score on a scale
Standard Deviation 0.90993
|
-0.7690 Score on a scale
Standard Deviation 0.90884
|
|
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Week 12
|
-1.5273 Score on a scale
Standard Deviation 1.27441
|
-1.0137 Score on a scale
Standard Deviation 1.17400
|
|
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Week 16
|
-1.7047 Score on a scale
Standard Deviation 1.32902
|
-1.1434 Score on a scale
Standard Deviation 1.26434
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with mCPDAI baseline and post-baseline measurements
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=309 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=306 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Week 4
|
-0.8 Score on a scale
Standard Deviation 1.57
|
-0.7 Score on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Week 8
|
-1.3 Score on a scale
Standard Deviation 1.71
|
-0.9 Score on a scale
Standard Deviation 1.86
|
|
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Week 12
|
-1.6 Score on a scale
Standard Deviation 1.80
|
-1.0 Score on a scale
Standard Deviation 1.87
|
|
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Week 16
|
-1.8 Score on a scale
Standard Deviation 1.97
|
-1.2 Score on a scale
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity
Outcome measures
| Measure |
Deucravacitinib
n=312 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=312 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Week 2
|
71 Participants
|
69 Participants
|
|
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Week 4
|
128 Participants
|
98 Participants
|
|
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Week 8
|
163 Participants
|
126 Participants
|
|
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Week 12
|
176 Participants
|
122 Participants
|
|
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Week 16
|
187 Participants
|
138 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with spondylitis in addition to peripheral joint involvement as their presentation of PsA
BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Outcome measures
| Measure |
Deucravacitinib
n=48 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=48 Participants
Placebo daily
|
|---|---|---|
|
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Week 16
|
17 Participants
|
4 Participants
|
|
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Week 2
|
2 Participants
|
1 Participants
|
|
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Week 4
|
6 Participants
|
1 Participants
|
|
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Week 8
|
12 Participants
|
5 Participants
|
|
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Week 12
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with WPAI baseline and post-baseline measurements
The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=306 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=309 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Absenteeism
|
-0.59 Score on a scale
Standard Deviation 21.406
|
1.56 Score on a scale
Standard Deviation 22.108
|
|
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Presenteeism
|
-13.97 Score on a scale
Standard Deviation 23.380
|
-5.96 Score on a scale
Standard Deviation 22.238
|
|
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Work Productivity
|
-13.71 Score on a scale
Standard Deviation 24.087
|
-5.79 Score on a scale
Standard Deviation 23.951
|
|
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Activity Impairment
|
-15.72 Score on a scale
Standard Deviation 25.226
|
-8.16 Score on a scale
Standard Deviation 24.178
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with EQ-5D-5L baseline and post-baseline measurements
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=307 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=309 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 4 Utility Score
|
0.0505 Score on a scale
Standard Deviation 0.17658
|
0.0655 Score on a scale
Standard Deviation 0.19080
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 16 Utility Score
|
0.0990 Score on a scale
Standard Deviation 0.21113
|
0.0770 Score on a scale
Standard Deviation 0.22126
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 4 Mobility
|
-0.2 Score on a scale
Standard Deviation 0.74
|
-0.2 Score on a scale
Standard Deviation 0.76
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 16 Mobility
|
-0.3 Score on a scale
Standard Deviation 0.92
|
-0.3 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 4 Self-Care
|
-0.1 Score on a scale
Standard Deviation 0.73
|
-0.2 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 16 Self-Care
|
-0.2 Score on a scale
Standard Deviation 0.83
|
-0.2 Score on a scale
Standard Deviation 0.81
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 4 Usual Activities
|
-0.1 Score on a scale
Standard Deviation 0.76
|
-0.2 Score on a scale
Standard Deviation 0.73
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 16 Usual Activities
|
-0.3 Score on a scale
Standard Deviation 0.84
|
-0.3 Score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 4 Pain/Discomfort
|
-0.3 Score on a scale
Standard Deviation 0.75
|
-0.3 Score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 16 Pain/Discomfort
|
-0.5 Score on a scale
Standard Deviation 0.89
|
-0.4 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 4 Anxiety/Depression
|
-0.1 Score on a scale
Standard Deviation 0.76
|
-0.1 Score on a scale
Standard Deviation 0.78
|
|
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Week 16 Anxiety/Depression
|
-0.1 Score on a scale
Standard Deviation 0.77
|
0.0 Score on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 16Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PROMIS baseline and post-baseline measurements
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Deucravacitinib
n=308 Participants
Deucravacitinib 6 mg daily
|
Placebo
n=309 Participants
Placebo daily
|
|---|---|---|
|
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
Week 4
|
-1.35 Score on a scale
Standard Deviation 6.958
|
-1.41 Score on a scale
Standard Deviation 6.156
|
|
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
Week 12
|
-1.76 Score on a scale
Standard Deviation 7.945
|
-1.48 Score on a scale
Standard Deviation 7.145
|
|
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
Week 16
|
-2.21 Score on a scale
Standard Deviation 7.447
|
-1.53 Score on a scale
Standard Deviation 7.134
|
Adverse Events
Deucravacitinib-Controlled
Serious events: 6 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo-Controlled
Serious events: 3 serious events
Other events: 93 other events
Deaths: 1 deaths
Apremilast-Controlled
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Deucravacitinib-Active Treatment
Serious events: 12 serious events
Other events: 90 other events
Deaths: 0 deaths
Placebo-Active Treatment
Serious events: 13 serious events
Other events: 106 other events
Deaths: 1 deaths
Apremilast-Active Treatment
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Deucravacitinib-Open Label Extension
Serious events: 16 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo-Open Label Extension
Serious events: 13 serious events
Other events: 61 other events
Deaths: 1 deaths
Apremilast-Open Label Extension
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deucravacitinib-Controlled
n=312 participants at risk
Deucravacitinib 6 mg daily (Week 0 - Week 16)
|
Placebo-Controlled
n=311 participants at risk
Placebo daily (Week 0 - Week 16)
|
Apremilast-Controlled
n=105 participants at risk
Apremilast 30 mg twice daily (Week 0 - Week 16)
|
Deucravacitinib-Active Treatment
n=292 participants at risk
Deucravacitinib 6 mg daily (Week 16 - Week 52)
|
Placebo-Active Treatment
n=292 participants at risk
Placebo to Deucravacitinib 6 mg daily (Week 16 - Week 52)
|
Apremilast-Active Treatment
n=90 participants at risk
Apremilast 30 mg twice daily (Week 16 - Week 52)
|
Deucravacitinib-Open Label Extension
n=245 participants at risk
Deucravacitinib 6 mg daily (OLE)
|
Placebo-Open Label Extension
n=254 participants at risk
Placebo to Deucravacitinib 6 mg daily (OLE)
|
Apremilast-Open Label Extension
n=70 participants at risk
Apremilast 30 mg twice daily (OLE)
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
1/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
1/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Cataract diabetic
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.32%
1/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
1/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric dysplasia
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.32%
1/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
1/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Sudden death
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Appendicitis
|
0.32%
1/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Otitis media
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.64%
2/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.68%
2/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
1/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Salpingitis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
1/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
1/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.32%
1/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
1/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.79%
2/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
1/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
1/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
1/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.32%
1/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.32%
1/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
1/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.39%
1/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.34%
1/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.32%
1/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.32%
1/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Deucravacitinib-Controlled
n=312 participants at risk
Deucravacitinib 6 mg daily (Week 0 - Week 16)
|
Placebo-Controlled
n=311 participants at risk
Placebo daily (Week 0 - Week 16)
|
Apremilast-Controlled
n=105 participants at risk
Apremilast 30 mg twice daily (Week 0 - Week 16)
|
Deucravacitinib-Active Treatment
n=292 participants at risk
Deucravacitinib 6 mg daily (Week 16 - Week 52)
|
Placebo-Active Treatment
n=292 participants at risk
Placebo to Deucravacitinib 6 mg daily (Week 16 - Week 52)
|
Apremilast-Active Treatment
n=90 participants at risk
Apremilast 30 mg twice daily (Week 16 - Week 52)
|
Deucravacitinib-Open Label Extension
n=245 participants at risk
Deucravacitinib 6 mg daily (OLE)
|
Placebo-Open Label Extension
n=254 participants at risk
Placebo to Deucravacitinib 6 mg daily (OLE)
|
Apremilast-Open Label Extension
n=70 participants at risk
Apremilast 30 mg twice daily (OLE)
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
11/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
15/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
11/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.4%
10/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
6/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.2%
11/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.82%
2/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.0%
5/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
3/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
2.2%
7/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
6/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
7/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
5/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
8/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
2/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
3/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.79%
2/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
7.1%
22/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.5%
17/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
7/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
19/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
30/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.9%
8/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
13/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
21/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
14/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.8%
21/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.2%
27/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
36/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
4/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
14/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
13/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
5/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
19/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
13/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.2%
27/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
28/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.9%
8/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.0%
27/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
16/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.6%
13/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.96%
3/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.96%
3/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
8/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
5/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
5/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.41%
1/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.79%
2/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
2/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.6%
5/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.2%
10/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
5/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
13/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
5/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.3%
8/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
6/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
2/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
4.2%
13/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
11/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.6%
8/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
4/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.4%
4/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
5/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.82%
2/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
3/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
2.6%
8/312 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
8/311 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
7/105 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
7/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
8/292 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/90 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.82%
2/245 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.8%
7/254 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
2/70 • All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [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