Trial Outcomes & Findings for A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis (NCT NCT03818035)
NCT ID: NCT03818035
Last Updated: 2026-01-23
Results Overview
Percentage of participants who achieved an absolute PASI \<3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent \[%\]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
880 participants
Primary outcome timeframe
Week 68
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI \>=5) until Week 60 or were not eligible to enter withdrawal (PASI \>=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8, and 16 from entering Group 2d.
|
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Open-label (Week 0 to Week 8)
STARTED
|
880
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
COMPLETED
|
822
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
NOT COMPLETED
|
58
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
STARTED
|
0
|
148
|
150
|
525
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Treated
|
0
|
148
|
149
|
525
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
COMPLETED
|
0
|
137
|
142
|
496
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
NOT COMPLETED
|
0
|
11
|
8
|
29
|
0
|
0
|
0
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
STARTED
|
0
|
0
|
0
|
0
|
0
|
136
|
137
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
7
|
6
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
129
|
131
|
0
|
|
Re-treatment (Week R0 Through Week R28)
STARTED
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
227
|
|
Re-treatment (Week R0 Through Week R28)
COMPLETED
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
219
|
|
Re-treatment (Week R0 Through Week R28)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI \>=5) until Week 60 or were not eligible to enter withdrawal (PASI \>=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8, and 16 from entering Group 2d.
|
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Open-label (Week 0 to Week 8)
Lack of Efficacy
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Lost to Follow-up
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Protocol Violation
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Withdrawal by Subject
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Adverse Event - Worsening of Psoriasis
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Adverse Event - Other
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Non-Compliance with Study Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Other
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open-label (Week 0 to Week 8)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Lack of Efficacy
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Lost to Follow-up
|
0
|
6
|
1
|
9
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Withdrawal by Subject
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Other Adverse Events
|
0
|
3
|
4
|
6
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Adverse Event, serious fatal
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Participants Started Retreatment Phase Within Study Part 2 before Week 68
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Double-blind (Week28 to Week68)
Other
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
9
|
3
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Other Adverse Events
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Non-compliance with study drug
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Not Signed ICF
|
0
|
0
|
0
|
0
|
0
|
5
|
4
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part3: Withdrawal (Week 68 to Week 220)
Retreatment started
|
0
|
0
|
0
|
0
|
0
|
112
|
115
|
0
|
|
Re-treatment (Week R0 Through Week R28)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Re-treatment (Week R0 Through Week R28)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Re-treatment (Week R0 Through Week R28)
Other Adverse Events
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Re-treatment (Week R0 Through Week R28)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Baseline characteristics by cohort
| Measure |
Part 1 Group 1: Guselkumab 100 mg
n=880 Participants
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
817 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=270 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 14.7 • n=270 Participants
|
|
Sex: Female, Male
Female
|
260 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
620 Participants
n=270 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=270 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=270 Participants
|
|
Race/Ethnicity, Customized
White
|
859 Participants
n=270 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=270 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
3 Participants
n=270 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=270 Participants
|
|
Region of Enrollment
FRANCE
|
52 Participants
n=270 Participants
|
|
Region of Enrollment
GERMANY
|
828 Participants
n=270 Participants
|
PRIMARY outcome
Timeframe: Week 68Population: For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c).
Percentage of participants who achieved an absolute PASI \<3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent \[%\]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=148 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=149 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
|
—
|
—
|
—
|
—
|
92.6 Percentage of participants
Interval 88.0 to 95.8
|
91.9 Percentage of participants
Interval 87.3 to 95.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68Population: ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c).
Time to improvement from baseline in PASI 75/90/100 response for participants with short disease duration (SDD) and longer disease duration (LDD) was reported. PASI was used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced numeric score ranging from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI responders were participants with \>=75%, \>=90%, 100% improvement in PASI respectively. For Part 2, data is reported only for those groups in which participants had PASI improvement post Week 28.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=347 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=357 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=523 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=178 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score
PASI 75
|
—
|
—
|
84.0 Days
Interval 83.0 to 105.0
|
—
|
84.0 Days
Interval 81.0 to 89.0
|
84.0 Days
Interval 81.0 to 90.0
|
84.0 Days
Interval 83.0 to 112.0
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score
PASI 90
|
—
|
—
|
114.0 Days
Interval 84.0 to 196.0
|
—
|
89.0 Days
Interval 84.0 to 134.0
|
106.0 Days
Interval 84.0 to 140.0
|
112.0 Days
Interval 84.0 to 153.0
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score
PASI 100
|
—
|
—
|
416.0 Days
Interval 198.0 to
NA signifies that lower limit of Inter-quartile range was not estimable due to insufficient number of participants with events.
|
—
|
141.0 Days
Interval 105.0 to 210.0
|
200.0 Days
Interval 113.0 to
NA signifies that upper limit of Inter-quartile range was not estimable due to insufficient number of participants with events.
|
308.0 Days
Interval 196.0 to 483.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220Population: ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set was used. Part 3, ITT set=all participants entering Part 3. N (overall number of participants analyzed)= number of participants evaluable for this outcome measure and 'n' (number analyzed)=number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm.
Percentage of participants with short (\<=2 years) and longer (\>2 years) disease duration who achieved an absolute PASI Score of 0, \<=1 and less than (\<) 3 was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=76 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=73 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=73 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=178 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=357 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=523 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=75 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
n=347 Participants
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
n=67 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
n=69 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
n=71 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
n=66 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI = 0 (Week 20)
|
—
|
—
|
—
|
—
|
49.3 Percentage of participants
|
32.7 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <=1 (Week 20)
|
—
|
—
|
—
|
—
|
67.8 Percentage of participants
|
54.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <3 (Week 20)
|
—
|
—
|
—
|
—
|
85.2 Percentage of participants
|
82.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI = 0 ( Week 28)
|
—
|
—
|
—
|
—
|
51.8 Percentage of participants
|
39.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <=1 (Week 28)
|
—
|
—
|
—
|
—
|
70.3 Percentage of participants
|
59.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <3 (Week 28)
|
—
|
—
|
—
|
—
|
86.8 Percentage of participants
|
83.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI = 0 (Week 68)
|
73.7 Percentage of participants
|
64.4 Percentage of participants
|
80.8 Percentage of participants
|
39.9 Percentage of participants
|
—
|
—
|
81.3 Percentage of participants
|
37.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <=1 (Week 68)
|
81.6 Percentage of participants
|
76.7 Percentage of participants
|
93.2 Percentage of participants
|
73.6 Percentage of participants
|
—
|
—
|
86.7 Percentage of participants
|
55.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <3 (Week 68)
|
93.4 Percentage of participants
|
90.4 Percentage of participants
|
94.5 Percentage of participants
|
88.8 Percentage of participants
|
—
|
—
|
90.7 Percentage of participants
|
79.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI = 0 (Week 116)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.9 Percentage of participants
|
4.3 Percentage of participants
|
12.7 Percentage of participants
|
1.5 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <=1 (Week 116)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25.4 Percentage of participants
|
5.8 Percentage of participants
|
18.3 Percentage of participants
|
3.0 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <3 (Week 116)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34.3 Percentage of participants
|
11.6 Percentage of participants
|
26.8 Percentage of participants
|
10.6 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI = 0 (Week 164)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.4 Percentage of participants
|
1.4 Percentage of participants
|
5.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <=1 (Week 164)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.4 Percentage of participants
|
1.4 Percentage of participants
|
7.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <3 (Week 164)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.9 Percentage of participants
|
2.9 Percentage of participants
|
12.7 Percentage of participants
|
3.0 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI = 0 (Week 220)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <=1 (Week 220)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
PASI <3 (Week 220)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.4 Percentage of participants
|
0 Percentage of participants
|
7.0 Percentage of participants
|
1.5 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 68 up to Week 220Population: For part 3, ITT analysis set included all participants entering study part 3 (either group 3a or 3b).
Percentage of participants who retain disease control (that is, absolute PASI score \<3 from Week 68 through Week 220 for participants with short (\<= 2 years) and longer (\>2 years) disease duration was reported. Control of disease was defined as participants with a PASI score \<3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=66 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=67 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=69 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=71 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3)
|
—
|
—
|
1.5 Percentage of participants
Interval 0.0 to 8.2
|
—
|
7.5 Percentage of participants
Interval 2.5 to 16.6
|
0.0 Percentage of participants
Interval 0.0 to 5.2
|
2.8 Percentage of participants
Interval 0.3 to 9.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220Population: For part 1 and 2, ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. n=0 signifies that specific timepoint was not applicable for that arm. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints
Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with \>= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with \>= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=136 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=137 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=525 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=880 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=148 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=149 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 75 (Week 20)
|
—
|
—
|
—
|
—
|
90.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 75 (Week 28)
|
—
|
—
|
—
|
—
|
90.7 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 90 (Week 20)
|
—
|
—
|
—
|
—
|
73.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 90 (Week 28)
|
—
|
—
|
—
|
—
|
76.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 100 (Week 20)
|
—
|
—
|
—
|
—
|
39.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 100 (Week 28)
|
—
|
—
|
—
|
—
|
44.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 75 (Week 68)
|
—
|
—
|
88.0 Percentage of participants
|
—
|
—
|
92.6 Percentage of participants
|
94.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 90 (Week 68)
|
—
|
—
|
73.7 Percentage of participants
|
—
|
—
|
91.9 Percentage of participants
|
85.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 100 (Week 68)
|
—
|
—
|
38.1 Percentage of participants
|
—
|
—
|
81.1 Percentage of participants
|
69.1 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 75 (Week 116)
|
27.9 Percentage of participants
|
20.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 75 (Week 164)
|
10.3 Percentage of participants
|
8.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 75 (Week 220)
|
5.1 Percentage of participants
|
4.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 90 (Week 116)
|
18.4 Percentage of participants
|
13.1 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 90 (Week 164)
|
7.4 Percentage of participants
|
5.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 90 (Week 220)
|
5.1 Percentage of participants
|
2.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 100 (Week 116)
|
9.6 Percentage of participants
|
7.3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 100 (Week 164)
|
5.9 Percentage of participants
|
2.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
PASI 100 (Week 220)
|
4.4 Percentage of participants
|
2.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 68 up to Week 220Population: For part 3, ITT analysis set included all participants entering study part 3 (either group 3a or 3b).
Time to loss of disease control (absolute PASI score \>5) after treatment withdrawal beyond Week 68 up to Week 220 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=136 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=137 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal
|
—
|
—
|
—
|
—
|
245 Days
Interval 203.0 to 286.0
|
189 Days
Interval 166.0 to 251.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20 and 28Population: ITT analysis set for part 1 included all participants treated with at least one dose of study agent.
Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=880 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
Week 12
|
—
|
—
|
—
|
—
|
17.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
Week 16
|
—
|
—
|
—
|
—
|
29.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
Week 20
|
—
|
—
|
—
|
—
|
39.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
Week 28
|
—
|
—
|
—
|
—
|
44.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b:Baseline (Week 0), Week 116, 164 and 220; Group 3c: Baseline (Re-Treatment [R] Week 0), Week R24Population: For part 1 and 2 ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.
Change from baseline (Week 0) in DLQI score were reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=136 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=137 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=525 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=227 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=880 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=148 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=149 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Week 28
|
—
|
—
|
—
|
—
|
-16.6 Score on scale
Standard Deviation 6.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Week 68
|
—
|
—
|
-17.1 Score on scale
Standard Deviation 5.8
|
—
|
—
|
-18.8 Score on scale
Standard Deviation 5.6
|
-17.0 Score on scale
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Week 116
|
-16.5 Score on scale
Standard Deviation 6.3
|
-15.5 Score on scale
Standard Deviation 6.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Week 164
|
-18.1 Score on scale
Standard Deviation 6.7
|
-17.4 Score on scale
Standard Deviation 7.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Week 220
|
-20.9 Score on scale
Standard Deviation 6.0
|
-16.3 Score on scale
Standard Deviation 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Re-Treatment till R24 weeks
|
—
|
—
|
—
|
-10.1 Score on scale
Standard Deviation 6.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Week 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Week 116, 164 and 220; Group 3c: Week R24Population: For part 1, 2 and 3 ITT analysis set was used. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm.
Percentage of participants who achieved a DLQI score 0/1 and \<5 was reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=136 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=137 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=525 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=67 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=880 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=148 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=149 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
n=69 Participants
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
n=71 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
n=66 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
n=227 Participants
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score 0/1 (Week 28)
|
—
|
—
|
—
|
—
|
60.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score<5 (Week 28)
|
—
|
—
|
—
|
—
|
78.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score 0/1 (Week 68)
|
—
|
—
|
61.9 Percentage of participants
|
—
|
—
|
83.1 Percentage of participants
|
77.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score<5 (Week 68)
|
—
|
—
|
78.9 Percentage of participants
|
—
|
—
|
89.2 Percentage of participants
|
85.2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score 0/1 (Week 116)
|
15.4 Percentage of participants
|
10.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score <5 (Week 116)
|
—
|
—
|
—
|
34.3 Percentage of participants
|
—
|
—
|
—
|
15.9 Percentage of participants
|
26.8 Percentage of participants
|
7.6 Percentage of participants
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score 0/1 (Week 164)
|
8.1 Percentage of participants
|
5.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score <5 (Week 164)
|
8.1 Percentage of participants
|
8.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score 0/1 (Week 220)
|
4.4 Percentage of participants
|
2.9 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score <5 (Week 220)
|
5.1 Percentage of participants
|
4.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score 0/1 RT24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
73.1 Percentage of participants
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
DLQI Score <5 RT24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
87.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Group 1: Baseline (Week 0), Week 12, 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 52 and 68, Group 3a, 3b: Baseline (Week 0), Week 80, 104, 116, 140, 164, 188, 212 and 220Population: For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm..
Percent change from baseline in the psoriasis affected BSA (%) was reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA)
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=126 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=107 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=492 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=861 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=141 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=142 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 116
|
-22.4 Percent Change
Standard Deviation 16.8
|
-19.8 Percent Change
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 140
|
-16.7 Percent Change
Standard Deviation 8.5
|
-19.6 Percent Change
Standard Deviation 11.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 164
|
-18.2 Percent Change
Standard Deviation 8.7
|
-20.6 Percent Change
Standard Deviation 11.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 12
|
—
|
—
|
—
|
—
|
-19.3 Percent Change
Standard Deviation 14.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 28
|
—
|
—
|
—
|
—
|
-23.8 Percent Change
Standard Deviation 15.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 52
|
—
|
—
|
-24.8 Percent Change
Standard Deviation 14.6
|
—
|
—
|
-25.1 Percent Change
Standard Deviation 15.1
|
-24.3 Percent Change
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 68
|
—
|
—
|
-25.0 Percent Change
Standard Deviation 14.6
|
—
|
—
|
-24.8 Percent Change
Standard Deviation 14.9
|
-24.3 Percent Change
Standard Deviation 15.8
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 80
|
-23.8 Percent Change
Standard Deviation 14.1
|
-23.6 Percent Change
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 104
|
-20.6 Percent Change
Standard Deviation 15.1
|
-22.5 Percent Change
Standard Deviation 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 188
|
-18.1 Percent Change
Standard Deviation 8.2
|
-20.4 Percent Change
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 212
|
-18.3 Percent Change
Standard Deviation 9.6
|
-19.3 Percent Change
Standard Deviation 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
At Week 220
|
-18.3 Percent Change
Standard Deviation 9.6
|
19.0 Percent Change
Standard Deviation 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220Population: For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.
Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 was reported. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=10 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=11 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=276 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=406 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=59 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=60 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Feet (Week 220)
|
-8.0 Score on scale
Standard Deviation NA
'NA' signifies that SD could could not be calculated for a single participant.
|
-4.0 Score on scale
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Hands (Week 28)
|
—
|
—
|
—
|
—
|
-3.4 Score on scale
Standard Deviation 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Feet (Week 28)
|
—
|
—
|
—
|
—
|
-3.1 Score on scale
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Hands (Week 68)
|
—
|
—
|
-4.0 Score on scale
Standard Deviation 3.2
|
—
|
—
|
-4.0 Score on scale
Standard Deviation 3.2
|
-4.5 Score on scale
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Feet (Week 68)
|
—
|
—
|
-4.1 Score on scale
Standard Deviation 3.6
|
—
|
—
|
-4.9 Score on scale
Standard Deviation 3.5
|
-4.6 Score on scale
Standard Deviation 3.7
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Hands (Week 116)
|
-2.2 Score on scale
Standard Deviation 4.3
|
-2.2 Score on scale
Standard Deviation 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Feet (Week 116)
|
-3.4 Score on scale
Standard Deviation 6.2
|
-3.5 Score on scale
Standard Deviation 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Hands (Week 164)
|
-4.5 Score on scale
Standard Deviation 3.5
|
-3.0 Score on scale
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Feet (Week 164)
|
-8.0 Score on scale
Standard Deviation NA
'NA' signifies that SD could could not be calculated for a single participant.
|
-3.6 Score on scale
Standard Deviation 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Hands (Week 220)
|
-4.3 Score on scale
Standard Deviation 2.5
|
-3.7 Score on scale
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220Population: For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.
Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of \>= 40 points in PSSD symptom score or sign score, and a \>= 3-point change in individual PSSD item scale scores was defined as clinically meaningful change (response).
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=41 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=31 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=492 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=863 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=138 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=140 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 68 (Sign)
|
—
|
—
|
-63.0 Score on scale
Standard Deviation 22.2
|
—
|
—
|
-71.7 Score on scale
Standard Deviation 16.4
|
-65.4 Score on scale
Standard Deviation 19.6
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 28 (Symptom)
|
—
|
—
|
—
|
—
|
-57.2 Score on scale
Standard Deviation 25.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 28 (Sign)
|
—
|
—
|
—
|
—
|
-62.1 Score on scale
Standard Deviation 22.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 68 (Symptom)
|
—
|
—
|
-58.6 Score on scale
Standard Deviation 25.1
|
—
|
—
|
-65.1 Score on scale
Standard Deviation 21.2
|
-58.7 Score on scale
Standard Deviation 23.3
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 116 (Symptom)
|
-52.3 Score on scale
Standard Deviation 25.7
|
-50.0 Score on scale
Standard Deviation 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 116 (Sign)
|
-56.1 Score on scale
Standard Deviation 25.6
|
-52.2 Score on scale
Standard Deviation 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 164 (Symptom)
|
-59.7 Score on scale
Standard Deviation 20.5
|
-54.0 Score on scale
Standard Deviation 26.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 164 (Sign)
|
-62.1 Score on scale
Standard Deviation 22.0
|
-50.4 Score on scale
Standard Deviation 26.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 220 (Symptom)
|
-56.0 Score on scale
Standard Deviation 22.9
|
-54.7 Score on scale
Standard Deviation 23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
At Week 220 (Sign)
|
-63.3 Score on scale
Standard Deviation 20.3
|
-54.7 Score on scale
Standard Deviation 28.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 68Population: For part 2, ITT analysis set included all randomized participants at Week 28 or treated with at least one dose of study agent within study part 2 (study group 2c) and those who had PSSD sign score \>=1 at Week 28.
Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score \>= 1 at Week 28 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=86 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=92 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=453 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 2a, 2b and 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28
|
—
|
—
|
—
|
—
|
30.2 Percentage of participants
Interval 22.1 to 39.4
|
21.7 Percentage of participants
Interval 14.9 to 30.0
|
14.8 Percentage of participants
Interval 12.1 to 17.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 20, 28, 36, 68Population: For part 2, Pharmacokinetic (PK) Intent-to-treat analysis set included all randomized participants who had at least post baseline PK sample available. . Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.
Serum trough guselkumab levels at Weeks 20, 28, 36 were analyzed. Serum samples were analyzed to determine trough concentrations of guselkumab using a validated specific, and sensitive method. Week 28 data are presented in Part 2 arms (Groups 2a and 2b) as these groups were established at Week 28, however pre-Week 28 trough concentrations are also reported under these groups to assess potential differences between Part 1 PK characteristics.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=147 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=145 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68
At Week 20
|
—
|
—
|
—
|
—
|
1.61 micrograms/mL
Standard Deviation 0.989
|
1.60 micrograms/mL
Standard Deviation 1.049
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68
At Week 28
|
—
|
—
|
—
|
—
|
1.58 micrograms/mL
Standard Deviation 1.010
|
1.67 micrograms/mL
Standard Deviation 1.076
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68
At Week 36
|
—
|
—
|
—
|
—
|
1.68 micrograms/mL
Standard Deviation 1.062
|
0.38 micrograms/mL
Standard Deviation 0.396
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68
At Week 68
|
—
|
—
|
—
|
—
|
1.56 micrograms/mL
Standard Deviation 0.960
|
0.31 micrograms/mL
Standard Deviation 0.377
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week R0 up to Week R24Population: Group 2d included the SRe participants who lost the disease control between Week 28 and 68, entered the re-treatment arm to receive guselkumab. Group 3c included SRe participants with fluctuating disease at Week 68 or loss of disease control at any other visit after Week 68, entered the re-treatment arm to receive guselkumab.
Percentage of participants who were re-treated due to loss of disease control (PASI \>5) and regain control of disease (PASI \<3) 24 weeks after start of re-treatment was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=9 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=227 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 2d and 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment
|
—
|
—
|
—
|
—
|
88.8 Percentage of participants
Interval 29.2 to 100.0
|
98.2 Percentage of participants
Interval 95.5 to 99.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: From Week 0 to Week 28; Group 2a,2b 2c: From Week 28 to Week 68; Group 3a, 3b: From Week 68 to Week 220; Group 2d, 3c: From Week R0 to Week R28Population: ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. n=0, signifies that specified timepoint was not applicable for that arm. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=9 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=136 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=525 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=137 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=880 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=148 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=149 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
n=236 Participants
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
Week 68 to Week 220
|
—
|
55.1 Percentage of participants
|
—
|
55.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
From Week 0 to Week 28
|
—
|
—
|
—
|
—
|
74.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
From Week 28 to Week 68
|
—
|
—
|
72.0 Percentage of participants
|
—
|
—
|
68.9 Percentage of participants
|
69.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
From Week R0 to Week R28
|
66.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
58.1 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1: Week 20, Group 2a, 2b,2c: Week 68 and Group 2d and 3c: Week R28Population: ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c). For part 3, ITT analysis set included all participants entering study part 3. 'n' (number analyzed)=number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm.
Number of participants with clinically significant laboratory abnormalities was reported. Data of participants with at least one lab abnormality is reported. Abnormality criteria: Aspartate Aminotransferase (AST) \>3, Alanine Aminotransferase (ALT).\>5. For arm 3a and 3b, no drug was administered, hence no laboratory data was collected, per planned analysis.
Outcome measures
| Measure |
Part 3 Group 3a: Withdrawal (Q8W)
n=9 Participants
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Withdrawal (Q16W)
n=227 Participants
Super responders from Group 2b with PASI score \<= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 2 Group 2c: Guselkumab 100 mg Q8W
n=525 Participants
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2a: Guselkumab 100 mg Q8W
n=880 Participants
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2b: Guselkumab 100 mg Q16W
n=148 Participants
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
n=149 Participants
Non Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \<=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score \> 0 at Week 20 and/or Week 28) with psoriasis of \>2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \<=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score \< 3 at Week 68) with psoriasis of \>2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
AST > 3 (Week 20)
|
—
|
—
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
AST > 3 (Week 68)
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
ALT > 5 (Week 68)
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
AST > 3 (Week R28)
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
ALT > 5 (Week R28)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Group 1: Guselkumab 100mg
Serious events: 38 serious events
Other events: 631 other events
Deaths: 1 deaths
Group 2a: Guselkumab 100 mg Q8W
Serious events: 7 serious events
Other events: 101 other events
Deaths: 0 deaths
Group 2b: Guselkumab 100 mg Q16W
Serious events: 6 serious events
Other events: 103 other events
Deaths: 0 deaths
Group 2c: Guselkumab 100 mg Q8W
Serious events: 33 serious events
Other events: 367 other events
Deaths: 1 deaths
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 3a Guselkumab 100 mg Q8W
Serious events: 3 serious events
Other events: 75 other events
Deaths: 0 deaths
Group 3b Guselkumab 100 mg Q16W
Serious events: 9 serious events
Other events: 75 other events
Deaths: 0 deaths
Group 3c Guselkumab 100 mg
Serious events: 8 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Group 1: Guselkumab 100mg
n=880 participants at risk
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
|
Group 2a: Guselkumab 100 mg Q8W
n=148 participants at risk
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Group 2b: Guselkumab 100 mg Q16W
n=149 participants at risk
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Group 2c: Guselkumab 100 mg Q8W
n=525 participants at risk
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 till Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
n=9 participants at risk
Participants from Groups 2a and 2b who lost control of disease (PASI \>=5) until Week 60 or were not eligible to enter withdrawal (PASI \>=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg at 0, 8, and 16weeks from entering Group 2d.
|
Group 3a Guselkumab 100 mg Q8W
n=136 participants at risk
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg by SC injection every 8 weeks (Q8W) at Week 68. Participants were followed until Week 220.
|
Group 3b Guselkumab 100 mg Q16W
n=137 participants at risk
Super responders from Group 2b with PASI score \<= 3 who were withdrawn from guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Week 68. Participants were followed until Week 220.
|
Group 3c Guselkumab 100 mg
n=227 participants at risk
Super responders with loss of disease control at or any visit after week 68 who entered the re-treatment arm and received guselkumab 100 mg by SC injection at re-treatment weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from Week 0 until Week 24 calculated from start of re-treatment due to loss disease control.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Splenic Haematoma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Chest Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Autoimmune Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Hypersensitivity
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Abscess of External Auditory Meatus
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Anal Abscess
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Bacterial Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Cellulitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Covid-19
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Erysipelas
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infectious Mononucleosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Post Procedural Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Abdominal Injury
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Cartilage Injury
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Traumatic Liver Injury
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Hepatic Neoplasm
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cerebellar Infarction
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Syncope
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Craniopharyngioma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Depression
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cerebral Infarction
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Nerve Compression
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Presyncope
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Pseudoradicular Syndrome
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity Pneumonitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Extremity Necrosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Hypertension
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
Other adverse events
| Measure |
Part 1 Group 1: Guselkumab 100mg
n=880 participants at risk
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
|
Group 2a: Guselkumab 100 mg Q8W
n=148 participants at risk
Super responders (SRe) (Psoriasis Area and Severity Index \[PASI\] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Group 2b: Guselkumab 100 mg Q16W
n=149 participants at risk
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Group 2c: Guselkumab 100 mg Q8W
n=525 participants at risk
Non-super responders (PASI score greater than \[\>\] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 till Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
|
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
n=9 participants at risk
Participants from Groups 2a and 2b who lost control of disease (PASI \>=5) until Week 60 or were not eligible to enter withdrawal (PASI \>=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg at 0, 8, and 16weeks from entering Group 2d.
|
Group 3a Guselkumab 100 mg Q8W
n=136 participants at risk
Super responders from Group 2a with PASI score \<= 3 were withdrawn from guselkumab 100 mg by SC injection every 8 weeks (Q8W) at Week 68. Participants were followed until Week 220.
|
Group 3b Guselkumab 100 mg Q16W
n=137 participants at risk
Super responders from Group 2b with PASI score \<= 3 who were withdrawn from guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Week 68. Participants were followed until Week 220.
|
Group 3c Guselkumab 100 mg
n=227 participants at risk
Super responders with loss of disease control at or any visit after week 68 who entered the re-treatment arm and received guselkumab 100 mg by SC injection at re-treatment weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from Week 0 until Week 24 calculated from start of re-treatment due to loss disease control.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Spontaneous Haematoma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Aortic Valve Sclerosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Cardiac Perfusion Defect
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Heart Valve Incompetence
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Left Ventricular Hypertrophy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Cardiac disorders
Tachycardia
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Congenital, familial and genetic disorders
Epidermal Naevus
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Congenital, familial and genetic disorders
Gilbert's Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Congenital, familial and genetic disorders
Keratosis Follicular
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Conductive Deafness
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Ear Pruritus
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Excessive Cerumen Production
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Endocrine disorders
Androgen Deficiency
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Endocrine disorders
Goitre
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Endocrine disorders
Hyperthyroidism
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Endocrine disorders
Hypothyroidism
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Blepharitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Borderline Glaucoma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Chalazion
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Conjunctival Irritation
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Dry Eye
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Eczema Eyelids
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Eye Pruritus
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Eyelid Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Glaucoma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Keratitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Lacrimation Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Ocular Hyperaemia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Ocular Hypertension
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Optic Nerve Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Retinal Haemorrhage
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Ulcerative Keratitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Vision Blurred
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Visual Acuity Reduced
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.7%
9/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Constipation
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Dental Caries
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Dental Discomfort
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Dental Necrosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
24/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.4%
5/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.5%
13/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
5/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Faeces Soft
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Flatulence
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gastritis
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gastrointestinal Polyp Haemorrhage
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gingival Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Gingival Recession
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Haemorrhoids Thrombosed
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Mouth Cyst
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
14/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Poor Dental Condition
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Tongue Discomfort
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Toothache
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Adverse Drug Reaction
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Application Site Erythema
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Asthenia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Chest Discomfort
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Chest Pain
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Chills
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Drug Ineffective
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Fatigue
|
1.6%
14/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Foreign Body Reaction
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
General Physical Health Deterioration
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Impaired Healing
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Influenza Like Illness
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Erythema
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
4.1%
6/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.95%
5/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Haematoma
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Hypersensitivity
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Induration
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Oedema
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Paraesthesia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Pruritus
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Reaction
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.95%
5/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Scar
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Injection Site Swelling
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Localised Oedema
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Oedema Peripheral
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Pain
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Peripheral Swelling
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Pyrexia
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Temperature Intolerance
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Vaccination Site Erythema
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
General disorders
Vaccination Site Pain
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Allergy to Arthropod Bite
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Allergy to Arthropod Sting
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Contrast Media Reaction
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Food Allergy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Mite Allergy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Immune system disorders
Seasonal Allergy
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Abscess
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Abscess Jaw
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Abscess Limb
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Abscess Oral
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Acarodermatitis
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Acne Pustular
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Acute Sinusitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Anal Abscess
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Bacterial Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Balanitis Candida
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Body Tinea
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Borrelia Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Breast Abscess
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Bronchitis
|
1.4%
12/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.9%
10/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
3/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Bronchitis Bacterial
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Candida Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Conjunctivitis
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Coronavirus Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
3/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Covid-19
|
1.1%
10/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.5%
13/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
14.7%
20/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
8.8%
12/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
9.3%
21/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Cystitis
|
1.0%
9/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Dermatitis Infected
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Dermatophytosis of Nail
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Ear Infection
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Eczema Infected
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Enteritis Infectious
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Epididymitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Erysipelas
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Erythema Migrans
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Folliculitis
|
0.80%
7/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Fungal Foot Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Fungal Infection
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Furuncle
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gastric Ulcer Helicobacter
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
18/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
3/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gastroenteritis Clostridial
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gastrointestinal Infection
|
1.4%
12/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.7%
9/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Genital Candidiasis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Genital Herpes
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Genital Infection Bacterial
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Genital Infection Fungal
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Hantaviral Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Helicobacter Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Herpes Simplex
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Herpes Virus Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Herpes Zoster
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Hordeolum
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infected Bite
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infected Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infected Dermal Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infectious Mononucleosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Infective Glossitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Influenza
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.4%
5/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.4%
5/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Joint Abscess
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Localised Infection
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Lyme Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Malassezia Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Mastitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Nail Bed Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Nasal Herpes
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Nasopharyngitis
|
24.3%
214/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
17.6%
26/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
15.4%
23/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
18.5%
97/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
12.5%
17/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
12.4%
17/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
14.1%
32/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Onychomycosis
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Oral Candidiasis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Oral Herpes
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Otitis Externa
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Otitis Media
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Otitis Media Viral
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Paronychia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Parotitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pharyngitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pneumonia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Post-Acute Covid-19 Syndrome
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pulpitis Dental
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pustule
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Rhinitis
|
1.5%
13/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Root Canal Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Scarlet Fever
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Sinusitis
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.6%
5/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Skin Bacterial Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Skin Candida
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Skin Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tinea Cruris
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tinea Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tinea Manuum
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tinea Pedis
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tinea Versicolour
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tonsillitis
|
1.4%
12/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
3/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tonsillitis Bacterial
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tooth Abscess
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Tooth Infection
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.5%
22/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.8%
4/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Urethritis Gonococcal
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Urinary Tract Infection
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Vaginal Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Viral Rash
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Viral Sinusitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Infections and infestations
Wound Infection
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Chemical Burn of Skin
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Eye Contusion
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Foreign Body in Eye
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Human Bite
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Inappropriate Schedule of Product Administration
|
1.2%
11/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
14/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
3/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Incision Site Erythema
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Incomplete Spinal Fusion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Joint Capsule Rupture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.95%
5/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Post Procedural Hypothyroidism
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Post Procedural Swelling
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Urinary Retention Postoperative
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.9%
4/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
5/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Wound
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.80%
7/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Aortic Bruit
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Aspartate Aminotransferase Abnormal
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Basophil Count Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Bilirubin Conjugated Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Bilirubin Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Bilirubin Unconjugated Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Cholesterol Increased
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Creatine Phosphokinase Abnormal
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.3%
20/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
4.0%
6/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
8/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.1%
7/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Creatinine Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Glucose Decreased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Potassium Abnormal
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Potassium Increased
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Pressure Increased
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Triglycerides Increased
|
1.2%
11/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.8%
4/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Urea Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Cardiac Murmur
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
1.0%
9/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.76%
4/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Haematocrit Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Heart Rate Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Hepatic Enzyme Increased
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
3/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Lipase Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Lipids Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Lymphocyte Count Decreased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Lymphocyte Morphology Abnormal
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Neutrophil Count Decreased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Neutrophil Count Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Platelet Count Increased
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Spermatozoa Abnormal
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Streptococcus Test Positive
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Transaminases Increased
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Tri-Iodothyronine Free Increased
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Weight Decreased
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
Weight Increased
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
White Blood Cell Count Increased
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Investigations
White Blood Cell Morphology Abnormal
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Fat Intolerance
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Gout
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.8%
4/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Selenium Deficiency
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Metabolism and nutrition disorders
Weight Fluctuation
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
41/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.4%
5/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
5.5%
29/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
5.9%
8/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.9%
4/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
26/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
4.1%
6/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
5.4%
8/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.5%
13/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.9%
4/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
3/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Extremity Contracture
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Jaw Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Nodal Osteoarthritis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
9/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
5/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.1%
6/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Sacral Pain
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acanthoma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital Warts
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Hepatic Neoplasm
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Adrenal Gland
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Eyelid
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic Naevus
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of Breast
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous Histiocytoma
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Anosmia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cerebellar Stroke
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Cubital Tunnel Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Disturbance in Attention
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Dizziness
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Gliosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Headache
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Hypoaesthesia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Migraine
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Migraine with Aura
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Nerve Compression
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Neuritis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Neuropathy Vitamin B6 Deficiency
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Orthostatic Intolerance
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Paraesthesia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Peripheral Nerve Lesion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Post Herpetic Neuralgia
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Precerebral Arteriosclerosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Presyncope
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Pseudoradicular Syndrome
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Radiculopathy
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Sciatica
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Syncope
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Thoracic Outlet Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Thoracic Radiculopathy
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Tremor
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Product Issues
Device Physical Property Issue
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Anxiety
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Attention Deficit Hyperactivity Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Burnout Syndrome
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Depression
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
2/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Depressive Symptom
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Insomnia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Panic Attack
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Personality Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Restlessness
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Sleep Disorder
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Sleep Disorder Due to A General Medical Condition
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Stress
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Haematuria
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Nephritis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Polycystic Ovaries
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Pruritus Genital
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Respiratory Symptom
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Sinusitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
11/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
2/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.9%
10/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.9%
4/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.8%
4/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity Pneumonitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Larynx Irritation
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pruritus
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.4%
12/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.95%
5/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.88%
2/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Disorder
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Obstruction
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Psoriasiform
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.38%
2/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.91%
8/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.1%
11/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Eczema Nummular
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic Psoriasis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.57%
3/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
1.2%
11/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Koebner Phenomenon
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Nail Dystrophy
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Nail Psoriasis
|
0.45%
4/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.95%
5/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
3/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.8%
4/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Perioral Dermatitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Pityriasis Rosea
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Polymorphic Light Eruption
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
9/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.4%
2/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.0%
3/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.95%
5/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.7%
5/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.9%
17/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.5%
8/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
7.4%
10/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
8.8%
12/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.1%
7/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.68%
6/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Fragility
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Maceration
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Texture Abnormal
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Solar Dermatitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Stasis Dermatitis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Toxic Skin Eruption
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.57%
5/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
1.3%
7/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Urticaria Contact
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Urticaria Physical
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Social circumstances
Stress at Work
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Blood Pressure Fluctuation
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Extremity Necrosis
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Flushing
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Haematoma
|
0.23%
2/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.74%
1/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.73%
1/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.44%
1/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Hot Flush
|
0.34%
3/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Hypertension
|
5.5%
48/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.7%
4/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.4%
5/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
5.9%
31/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
3/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
2.2%
3/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
3.1%
7/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.68%
1/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.67%
1/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Peripheral Venous Disease
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
Varicose Vein
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.19%
1/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Vascular disorders
White Coat Hypertension
|
0.11%
1/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Nervous system disorders
Nail psoriasis
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
22.2%
2/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/880 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/148 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/149 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/525 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
11.1%
1/9 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/136 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/137 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
0.00%
0/227 • Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
|
Additional Information
GUIDE-Study Responsible Physician
Janssen Research & Development LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER