Trial Outcomes & Findings for A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (NCT NCT05704738)
NCT ID: NCT05704738
Last Updated: 2026-08-28
Results Overview
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
532 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2026-08-28
Participant Flow
This trial was conducted at 247 centers in Asia, Europe, Latin America, and North America between April 2023 to November 2025. Adolescent participants with moderate to severe atopic dermatitis (AD) were randomized 4:3:3 into 3 treatment groups during initiation period (24 Weeks).
Based on achieving validated investigator's global assessment for AD score of 0 (clear) or 1 (almost clear) with a ≥ 2-point reduction from baseline (vIGA-AD 0/1) or achievement of ≥ 75% reduction from baseline in eczema area and severity index score (EASI 75) at Week 24, and whether therapies consistent with AD rescue were used, participants were assigned to either maintenance period or open-label period.
Participant milestones
| Measure |
Initiation Period: Placebo ± TCS/TCI
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
Maintenance Period: Placebo ± TCS/TCI
Participants who were initially randomized to receive placebo Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, continued to receive placebo via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 150mg Q8W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 150mg rocatinlimab via SC injection every 8 weeks (Q8W) for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 150mg Q4W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue receiving 150mg rocatinlimab via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 300mg Q8W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 300mg rocatinlimab via SC injection Q8W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 300mg Q4W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue to receive 300mg rocatinlimab via SC injection Q4W for an additional 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
OLRT Period: Roca 300mg Q4W OL From Placebo
Participants from the blinded maintenance period initially randomized to receive placebo who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label (OL) rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of open-label retreatment (OLRT) period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
Open-label Period: Roca 300mg Q4W OL From Placebo
Participants who were initially randomized to receive placebo in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue, received rocatinlimab 300mg via SC injection Q4W for 28 weeks in open-label. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W
Participants initially randomized to rocatinlimab 150mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300mg Q4W OL From Roca 300mg Q4W
Participants initially randomized to rocatinlimab 300mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Initiation Period (Baseline - Week 24)
STARTED
|
157
|
158
|
217
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Full Analysis Set (FAS)
|
157
|
158
|
217
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Participants Received Investigational Product (IP)
|
157
|
157
|
215
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
COMPLETED
|
141
|
144
|
203
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
NOT COMPLETED
|
16
|
14
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
STARTED
|
0
|
0
|
0
|
34
|
48
|
43
|
33
|
88
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
COMPLETED
|
0
|
0
|
0
|
16
|
39
|
37
|
25
|
73
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
18
|
9
|
6
|
8
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLRT Period (Week 25 - Week 52)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
7
|
5
|
7
|
14
|
0
|
0
|
0
|
|
OLRT Period (Week 25 - Week 52)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
7
|
5
|
6
|
14
|
0
|
0
|
0
|
|
OLRT Period (Week 25 - Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-label Period (Week 24 - Week 52)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
107
|
53
|
82
|
|
Open-label Period (Week 24 - Week 52)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
102
|
51
|
73
|
|
Open-label Period (Week 24 - Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
9
|
Reasons for withdrawal
| Measure |
Initiation Period: Placebo ± TCS/TCI
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
Maintenance Period: Placebo ± TCS/TCI
Participants who were initially randomized to receive placebo Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, continued to receive placebo via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 150mg Q8W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 150mg rocatinlimab via SC injection every 8 weeks (Q8W) for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 150mg Q4W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue receiving 150mg rocatinlimab via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 300mg Q8W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 300mg rocatinlimab via SC injection Q8W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 300mg Q4W ± TCS/TCI
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue to receive 300mg rocatinlimab via SC injection Q4W for an additional 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
OLRT Period: Roca 300mg Q4W OL From Placebo
Participants from the blinded maintenance period initially randomized to receive placebo who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label (OL) rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of open-label retreatment (OLRT) period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
Open-label Period: Roca 300mg Q4W OL From Placebo
Participants who were initially randomized to receive placebo in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue, received rocatinlimab 300mg via SC injection Q4W for 28 weeks in open-label. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W
Participants initially randomized to rocatinlimab 150mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300mg Q4W OL From Roca 300mg Q4W
Participants initially randomized to rocatinlimab 300mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Initiation Period (Baseline - Week 24)
Decision by sponsor
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Ineligibility determined
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Non-compliance
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Adverse Event
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Participant request
|
13
|
9
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Requirement for alternative therapy
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initiation Period (Baseline - Week 24)
Participants never received IP
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
Non-compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
Participant request
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 24 - Week 52)
Switched to OLRT
|
0
|
0
|
0
|
15
|
7
|
5
|
7
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLRT Period (Week 25 - Week 52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLRT Period (Week 25 - Week 52)
Participant request
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-label Period (Week 24 - Week 52)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Open-label Period (Week 24 - Week 52)
Participant request
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
4
|
|
Open-label Period (Week 24 - Week 52)
Protocol deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-label Period (Week 24 - Week 52)
Protocol specified criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Baseline characteristics by cohort
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150 mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150 mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300 mg at Week 2.
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.8 years
STANDARD_DEVIATION 1.6 • n=31 Participants
|
14.7 years
STANDARD_DEVIATION 1.7 • n=49 Participants
|
14.6 years
STANDARD_DEVIATION 1.7 • n=80 Participants
|
14.7 years
STANDARD_DEVIATION 1.7 • n=29 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=31 Participants
|
77 Participants
n=49 Participants
|
109 Participants
n=80 Participants
|
255 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=31 Participants
|
81 Participants
n=49 Participants
|
108 Participants
n=80 Participants
|
277 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
White
|
91 Participants
n=31 Participants
|
79 Participants
n=49 Participants
|
116 Participants
n=80 Participants
|
286 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Asian
|
57 Participants
n=31 Participants
|
57 Participants
n=49 Participants
|
84 Participants
n=80 Participants
|
198 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=31 Participants
|
14 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
30 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=31 Participants
|
8 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
18 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
21 Participants
n=31 Participants
|
27 Participants
n=49 Participants
|
34 Participants
n=80 Participants
|
82 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
136 Participants
n=31 Participants
|
131 Participants
n=49 Participants
|
183 Participants
n=80 Participants
|
450 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to randomized treatment.
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
|
17 Participants
|
56 Participants
|
79 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 24
|
38 Participants
|
90 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
|
43 Participants
|
83 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
|
20 Participants
|
34 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of daily worst pruritus NRS score ≥ 4 were included in the analysis.
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=145 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=141 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=195 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
|
20 Participants
|
38 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
|
19 Participants
|
63 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of daily worst pruritus NRS score ≥ 4 were included in the analysis.
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=145 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=141 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=195 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
|
16 Participants
|
41 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
|
21 Participants
|
63 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of AD skin pain NRS score ≥ 4 were included in the analysis.
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=117 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=111 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=154 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
|
17 Participants
|
41 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
|
17.2 percentage of participants
|
8.9 percentage of participants
|
10.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
|
24.2 percentage of participants
|
10.8 percentage of participants
|
11.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward \[WOCF\]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
|
-1.16 score on a scale
Standard Error 0.28 • Interval 0.28 to
|
-2.44 score on a scale
Standard Error 0.28 • Interval 0.28 to
|
-2.61 score on a scale
Standard Error 0.25 • Interval 0.25 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
|
-0.91 score on a scale
Standard Error 0.29 • Interval 0.29 to
|
-2.60 score on a scale
Standard Error 0.29 • Interval 0.29 to
|
-2.84 score on a scale
Standard Error 0.26 • Interval 0.26 to
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
|
-1.5 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-2.9 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-3.2 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in SCORAD Itch VAS Score at Week 24
|
-1.1 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-3.2 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-3.5 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants aged ≥ 16 years old at enrollment with baseline DLQI ≥ 4 were included in the analysis.
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=52 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=46 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=66 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
|
14 Participants
|
27 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants aged ≥ 16 years old at enrollment with baseline DLQI ≥ 4 were included in the analysis.
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=58 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=57 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=78 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
|
-1.6 score on a scale
Standard Error 0.8 • Interval 0.8 to
|
-5.1 score on a scale
Standard Error 0.8 • Interval 0.8 to
|
-6.4 score on a scale
Standard Error 0.7 • Interval 0.7 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants aged \< 16 years old at enrollment with baseline DLQI ≥ 4 were included in the analysis.
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of child patients suffering from skin disease. The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=99 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=101 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=139 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
|
-3.4 score on a scale
Standard Error 0.5 • Interval 0.5 to
|
-5.4 score on a scale
Standard Error 0.5 • Interval 0.5 to
|
-5.6 score on a scale
Standard Error 0.5 • Interval 0.5 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline POEM score ≥ 4 were included in the analysis.
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=147 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=146 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=205 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
|
54 Participants
|
103 Participants
|
143 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in POEM Score at Week 24
|
-1.7 score on a scale
Standard Error 0.9 • Interval 0.9 to
|
-6.9 score on a scale
Standard Error 0.8 • Interval 0.8 to
|
-7.7 score on a scale
Standard Error 0.8 • Interval 0.8 to
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of AD skin pain NRS score ≥ 4 were included in the analysis.
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=117 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=111 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=154 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
|
22 Participants
|
38 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
|
-0.80 score on a scale
Standard Error 0.29 • Interval 0.29 to
|
-2.31 score on a scale
Standard Error 0.29 • Interval 0.29 to
|
-2.37 score on a scale
Standard Error 0.26 • Interval 0.26 to
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
|
-1.19 score on a scale
Standard Error 0.28 • Interval 0.28 to
|
-2.26 score on a scale
Standard Error 0.28 • Interval 0.28 to
|
-2.20 score on a scale
Standard Error 0.26 • Interval 0.26 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment were included in the analysis. Only participants with baseline weekly average of daily AD skin pain NRS score ≥ 3 were included in the analysis.
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=129 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=126 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=170 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
|
22 Participants
|
57 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment were included in the analysis. Only participants with baseline weekly average of daily AD skin pain NRS score ≥ 3 were included in the analysis.
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=129 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=126 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=170 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
|
32 Participants
|
50 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
|
-1.07 score on a scale
Standard Error 0.27 • Interval 0.27 to
|
-2.22 score on a scale
Standard Error 0.27 • Interval 0.27 to
|
-2.12 score on a scale
Standard Error 0.25 • Interval 0.25 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline HADS-anxiety subscale score ≥ 8 were included in the analysis.
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=21 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=20 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=25 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
|
10 Participants
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline HADS-depression subscale score ≥ 8 were included in the analysis.
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=6 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=16 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=16 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
|
3 Participants
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the anxiety.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in HADS-anxiety Subscale Score at Week 24
|
-0.4 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-0.8 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-0.7 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the depression.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=158 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=217 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Change From Baseline in HADS-depression Subscale Score at Week 24
|
0.3 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
-0.2 score on a scale
Standard Error 0.3 • Interval 0.3 to
|
0.1 score on a scale
Standard Error 0.2 • Interval 0.2 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline SCORAD score ≥ 8.7 were included in the analysis.
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome measures
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=147 Participants
Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks (in combination with topical corticosteroids \[TCS\]/topical calcineurin inhibitors \[TCI\] for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=151 Participants
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=209 Participants
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
|---|---|---|---|
|
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
|
78 Participants
|
117 Participants
|
161 Participants
|
Adverse Events
Initiation Period: Placebo ± TCS/TCI
Serious events: 6 serious events
Other events: 65 other events
Deaths: 0 deaths
Initiation Period: Roca 150mg Q4W ± TCS/TCI
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Initiation Period: Roca 300mg Q4W ± TCS/TCI
Serious events: 4 serious events
Other events: 122 other events
Deaths: 0 deaths
Maintenance Period: Placebo ± TCS/TCI
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Maintenance Period: Roca 150mg Q8W ± TCS/TCI
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Maintenance Period: Roca 150mg Q4W ± TCS/TCI
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Maintenance Period: Roca 300mg Q8W ± TCS/TCI
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Maintenance Period: Roca 300mg Q4W ± TCS/TCI
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
OLRT Period: Roca 300mg Q4W OL From Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Open-label Period: Roca 300mg Q4W OL From Placebo
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Open-label Period: Roca 300 mg Q4W OL From Roca 300mg Q4W
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 participants at risk
Participants were administered matching placebo via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=156 participants at risk
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=216 participants at risk
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
Maintenance Period: Placebo ± TCS/TCI
n=34 participants at risk
Participants who were initially randomized to receive placebo Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, continued to receive placebo via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 150mg Q8W ± TCS/TCI
n=48 participants at risk
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 150mg rocatinlimab via SC injection Q8W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 150mg Q4W ± TCS/TCI
n=43 participants at risk
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue receiving 150mg rocatinlimab via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 300mg Q8W ± TCS/TCI
n=33 participants at risk
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 300mg rocatinlimab via SC injection Q8W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 300mg Q4W ± TCS/TCI
n=88 participants at risk
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue to receive 300mg rocatinlimab via SC injection Q4W for an additional 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
OLRT Period: Roca 300mg Q4W OL From Placebo
n=15 participants at risk
Participants from the blinded maintenance period initially randomized to receive placebo who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300 mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W
n=7 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300 mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W
n=5 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W
n=7 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W
n=14 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300 mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
Open-label Period: Roca 300mg Q4W OL From Placebo
n=107 participants at risk
Participants who were initially randomized to receive placebo in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue, received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W
n=53 participants at risk
Participants initially randomized to rocatinlimab 150mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300 mg Q4W OL From Roca 300mg Q4W
n=81 participants at risk
Participants initially randomized to rocatinlimab 300mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.9%
1/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.0%
1/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Focal peritonitis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.1%
1/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.1%
1/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Traumatic subarachnoid haemorrhage
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
1/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory myofibroblastic tumour
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.2%
1/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
Other adverse events
| Measure |
Initiation Period: Placebo ± TCS/TCI
n=157 participants at risk
Participants were administered matching placebo via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose at Week 2.
|
Initiation Period: Roca 150mg Q4W ± TCS/TCI
n=156 participants at risk
Participants were administered 150mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 150mg at Week 2.
|
Initiation Period: Roca 300mg Q4W ± TCS/TCI
n=216 participants at risk
Participants were administered 300mg rocatinlimab via SC injection Q4W for 24 weeks (in combination with TCS/TCI for the combination therapy cohort) with a loading dose of 300mg at Week 2.
|
Maintenance Period: Placebo ± TCS/TCI
n=34 participants at risk
Participants who were initially randomized to receive placebo Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, continued to receive placebo via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 150mg Q8W ± TCS/TCI
n=48 participants at risk
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 150mg rocatinlimab via SC injection Q8W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 150mg Q4W ± TCS/TCI
n=43 participants at risk
Participants who were initially randomized to receive rocatinlimab 150mg Q4W in the initiation treatment period and achieved either vIGA AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue receiving 150mg rocatinlimab via SC injection Q4W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
Maintenance Period: Roca 300mg Q8W ± TCS/TCI
n=33 participants at risk
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to receive 300mg rocatinlimab via SC injection Q8W for 28 weeks, in combination with TCS/TCI for the combination therapy cohort only. Participants randomized to Q8W regimens received placebo during the weeks when rocatinlimab was not administered.
|
Maintenance Period: Roca 300mg Q4W ± TCS/TCI
n=88 participants at risk
Participants who were initially randomized to receive rocatinlimab 300mg Q4W in the initiation treatment period and achieved either vIGA-AD 0/1 or EASI 75 at Week 24, without use of therapies concordant with AD, were re randomized to continue to receive 300mg rocatinlimab via SC injection Q4W for an additional 28 weeks, in combination with TCS/TCI for the combination therapy cohort only.
|
OLRT Period: Roca 300mg Q4W OL From Placebo
n=15 participants at risk
Participants from the blinded maintenance period initially randomized to receive placebo who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300 mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W
n=7 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300 mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W
n=5 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 150mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W
n=7 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q8W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W
n=14 participants at risk
Participants from the blinded maintenance period initially randomized to receive rocatinlimab 300mg via SC injection Q4W, who experienced relapse, defined as a ≥ 2-point worsening in vIGA-AD score from Week 24 (among those with vIGA-AD 0/1 at Week 24), a ≥ 50% loss of EASI improvement (among those who met EASI-75), or disease activity warranting rescue therapy were assigned to receive open-label rocatinlimab 300 mg via SC injection Q4W for the remainder of the trial. After 12 weeks of OLRT, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first OLRT dose).
|
Open-label Period: Roca 300mg Q4W OL From Placebo
n=107 participants at risk
Participants who were initially randomized to receive placebo in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue, received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W
n=53 participants at risk
Participants initially randomized to rocatinlimab 150mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
Open-label Period: Roca 300 mg Q4W OL From Roca 300mg Q4W
n=81 participants at risk
Participants initially randomized to rocatinlimab 300mg in the initiation treatment period who did not achieve vIGA-AD 0/1 or EASI 75 at Week 24, or who had initiated therapies concordant with AD rescue received rocatinlimab 300mg via SC injection Q4W for 28 weeks in OL. After 12 weeks of open-label period, continued treatment required meeting at least one predefined improvement criterion (≥25% improvement in EASI or ≥1-point improvement in vIGA-AD, from baseline or from the first open-label dose).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.3%
2/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.6%
4/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.6%
12/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.2%
3/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.1%
2/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
2/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.5%
7/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.4%
6/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
3/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.2%
9/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.2%
2/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.0%
6/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.1%
1/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
2/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.8%
3/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.8%
2/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.7%
3/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Chills
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.5%
7/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.6%
10/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.6%
6/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
1/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Pyrexia
|
5.1%
8/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
23.7%
37/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
19.0%
41/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.2%
2/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.7%
2/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.1%
1/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
8.4%
9/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.5%
2/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
COVID-19
|
1.3%
2/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.6%
4/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
4/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Dengue fever
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
1/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Furuncle
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.9%
1/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.2%
5/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.7%
8/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.1%
1/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.7%
2/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.1%
2/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
2/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Influenza
|
1.9%
3/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.1%
8/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.2%
7/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.9%
1/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.6%
7/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.3%
4/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.1%
2/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.8%
6/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.7%
5/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.8%
2/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.5%
2/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
20/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
10.9%
17/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
11.1%
24/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
8.8%
3/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
12.5%
6/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.0%
3/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.1%
2/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
12.5%
11/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
11.2%
12/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
11.3%
6/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
12.3%
10/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Pharyngitis
|
1.9%
3/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.2%
5/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.4%
3/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.1%
1/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.0%
3/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
2/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.8%
2/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.5%
2/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.9%
1/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
1/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
2/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.7%
3/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Sinusitis
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.9%
1/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
1/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.1%
1/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.2%
1/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Tonsillitis
|
1.9%
3/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
2/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.2%
2/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.1%
1/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
1/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.2%
1/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
12/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.0%
14/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.4%
16/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
8.8%
3/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.2%
3/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.3%
4/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.1%
3/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.4%
3/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
1/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
2/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.7%
5/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.7%
3/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.7%
3/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.0%
1/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.1%
1/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
1/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.2%
1/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
1/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.1%
2/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.46%
1/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
4/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.2%
1/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
3.8%
6/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.0%
14/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
15.3%
33/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.2%
2/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
1/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.4%
3/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.7%
5/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.8%
2/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.5%
2/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.3%
2/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.9%
1/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.2%
2/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
2.3%
1/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
14.3%
1/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.5%
4/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.7%
12/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.6%
12/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.2%
3/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.7%
2/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.0%
1/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.7%
1/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.1%
1/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
8.4%
9/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.4%
5/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
9.9%
8/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
15.3%
24/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
4.5%
7/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.6%
12/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
5.9%
2/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
3.7%
4/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.9%
1/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
7.4%
6/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.64%
1/157 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.64%
1/156 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.4%
3/216 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/34 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/48 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/43 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
6.1%
2/33 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/88 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/15 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/7 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/14 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.93%
1/107 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/53 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
1.2%
1/81 • For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.
All-cause mortality is reported for all participants randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER