Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (NCT NCT02065557)
NCT ID: NCT02065557
Last Updated: 2020-10-05
Results Overview
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \> 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Week 8
Results posted on
2020-10-05
Participant Flow
Prior to Protocol Amendment 4, participants were randomized 3:2 at baseline to adalimumab induction high dose or adalimumab induction standard dose. At Week 8, those demonstrating a clinical response per Partial Mayo Score (PMS) were randomized 2:2:1 to adalimumab maintenance standard dose, adalimumab maintenance high dose, or maintenance placebo.
After Protocol Amendment 4, participants received adalimumab induction high dose open-label. At Week 8, those demonstrating a clinical response per PMS were randomized in a 1:1 ratio to adalimumab maintenance standard dose or adalimumab maintenance high dose. "Integrated Study" data includes data from both the Main Study and the Japan Sub-Study.
Participant milestones
| Measure |
Integrated Study: Induction Standard Dose (I-SD)
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study: Induction High Dose (I-HD)
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study: Induction High Dose Open Label (I-HD-OL)
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study: Maintenance Placebo (M-PL)
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
|
Integrated Study: Maintenance Standard Dose (M-SD)
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] every other week \[eow\]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
|
Integrated Study: Maintenance High Dose (M-HD)
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] every week \[ew\]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
|
|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
32
|
51
|
18
|
0
|
0
|
0
|
|
Induction Period
Enrolled in Main Study
|
30
|
47
|
16
|
0
|
0
|
0
|
|
Induction Period
Enrolled in Japan Sub-study
|
2
|
4
|
2
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
22
|
43
|
16
|
0
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
10
|
8
|
2
|
0
|
0
|
0
|
|
Maintenance Period
STARTED
|
0
|
0
|
0
|
12
|
33
|
36
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
0
|
11
|
25
|
32
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
8
|
4
|
Reasons for withdrawal
| Measure |
Integrated Study: Induction Standard Dose (I-SD)
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study: Induction High Dose (I-HD)
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study: Induction High Dose Open Label (I-HD-OL)
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study: Maintenance Placebo (M-PL)
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
|
Integrated Study: Maintenance Standard Dose (M-SD)
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] every other week \[eow\]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
|
Integrated Study: Maintenance High Dose (M-HD)
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] every week \[ew\]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
|
|---|---|---|---|---|---|---|
|
Induction Period
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Induction Period
Requires Alternative/Prohibited Therapy
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Induction Period
Non-Responder at Week 8
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Induction Period
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Requires Alternative/Prohibited Therapy
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
5
|
2
|
|
Maintenance Period
Subject Non-Compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Integrated Study (Main + Japan Sub- Study): I-SD
n=32 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub- Study): I-HD
n=51 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub- Study): I-HD-OL
n=18 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.7 years
STANDARD_DEVIATION 2.66 • n=5 Participants
|
13.8 years
STANDARD_DEVIATION 3.06 • n=7 Participants
|
13.8 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 2.90 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
No Ethnicity
|
29 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Full Mayo Score (FMS)
|
7.8 score on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
7.7 score on a scale
STANDARD_DEVIATION 1.25 • n=7 Participants
|
7.7 score on a scale
STANDARD_DEVIATION 1.09 • n=5 Participants
|
7.8 score on a scale
STANDARD_DEVIATION 1.20 • n=4 Participants
|
|
Partial Mayo Score (PMS)
|
5.7 score on a scale
STANDARD_DEVIATION 1.14 • n=5 Participants
|
5.5 score on a scale
STANDARD_DEVIATION 1.24 • n=7 Participants
|
5.5 score on a scale
STANDARD_DEVIATION 1.06 • n=5 Participants
|
5.6 score on a scale
STANDARD_DEVIATION 1.17 • n=4 Participants
|
|
Endoscopy Subscore
|
2.1 score on a scale
STANDARD_DEVIATION 0.34 • n=5 Participants
|
2.2 score on a scale
STANDARD_DEVIATION 0.40 • n=7 Participants
|
2.2 score on a scale
STANDARD_DEVIATION 0.43 • n=5 Participants
|
2.2 score on a scale
STANDARD_DEVIATION 0.38 • n=4 Participants
|
|
Rectal Bleeding Subscore
|
1.4 score on a scale
STANDARD_DEVIATION 0.93 • n=5 Participants
|
1.5 score on a scale
STANDARD_DEVIATION 0.88 • n=7 Participants
|
1.4 score on a scale
STANDARD_DEVIATION 0.97 • n=5 Participants
|
1.5 score on a scale
STANDARD_DEVIATION 0.91 • n=4 Participants
|
|
Physicians Global Assessment Subscore
|
2.2 score on a scale
STANDARD_DEVIATION 0.40 • n=5 Participants
|
2.2 score on a scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
2.2 score on a scale
STANDARD_DEVIATION 0.38 • n=5 Participants
|
2.2 score on a scale
STANDARD_DEVIATION 0.41 • n=4 Participants
|
|
Stool Frequency Subscore
|
2.1 score on a scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
1.8 score on a scale
STANDARD_DEVIATION 0.88 • n=7 Participants
|
1.9 score on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
1.9 score on a scale
STANDARD_DEVIATION 0.83 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Intent-to-Treat (ITT): all participants who received at least 1 dose of study drug during the Induction period; analyzed as enrolled/randomized. Non-responder imputation (NRI): missing data is imputed as not having met the endpoint.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \> 1.
Outcome measures
| Measure |
Main Study: I-SD
n=30 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-HD
n=47 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-SD + I-HD
n=77 Participants
Combined I-SD + I-HD arms (see above).
|
Main Study: I-HD-OL
n=16 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD
n=32 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-HD
n=51 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
n=83 Participants
Combined I-SD + I-HD arms (see above).
|
Integrated Study (Main + Japan Sub-Study): I-HD-OL
n=18 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
|---|---|---|---|---|---|---|---|---|
|
Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period
|
43.3 percentage of participants
Interval 25.46 to 62.57
|
59.6 percentage of participants
Interval 44.27 to 73.63
|
53.2 percentage of participants
Interval 41.52 to 64.71
|
68.8 percentage of participants
Interval 41.34 to 88.98
|
40.6 percentage of participants
Interval 23.7 to 59.36
|
58.8 percentage of participants
Interval 44.17 to 72.42
|
51.8 percentage of participants
Interval 40.56 to 62.92
|
66.7 percentage of participants
Interval 40.99 to 86.66
|
PRIMARY outcome
Timeframe: Week 52Population: Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Outcome measures
| Measure |
Main Study: I-SD
n=12 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-HD
n=31 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-SD + I-HD
n=31 Participants
Combined I-SD + I-HD arms (see above).
|
Main Study: I-HD-OL
n=62 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD
n=12 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-HD
n=33 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
n=35 Participants
Combined I-SD + I-HD arms (see above).
|
Integrated Study (Main + Japan Sub-Study): I-HD-OL
n=68 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
|---|---|---|---|---|---|---|---|---|
|
Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
29.0 percentage of participants
Interval 14.22 to 48.04
|
45.2 percentage of participants
Interval 27.32 to 63.97
|
37.1 percentage of participants
Interval 25.16 to 50.31
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
27.3 percentage of participants
Interval 13.3 to 45.52
|
42.9 percentage of participants
Interval 26.32 to 60.65
|
35.3 percentage of participants
Interval 24.08 to 47.83
|
SECONDARY outcome
Timeframe: Week 52Population: Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.
Outcome measures
| Measure |
Main Study: I-SD
n=12 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-HD
n=31 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-SD + I-HD
n=31 Participants
Combined I-SD + I-HD arms (see above).
|
Main Study: I-HD-OL
n=62 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD
n=12 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-HD
n=33 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
n=35 Participants
Combined I-SD + I-HD arms (see above).
|
Integrated Study (Main + Japan Sub-Study): I-HD-OL
n=68 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
|---|---|---|---|---|---|---|---|---|
|
Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
61.3 percentage of participants
Interval 42.19 to 78.15
|
67.7 percentage of participants
Interval 48.63 to 83.32
|
64.5 percentage of participants
Interval 51.34 to 76.26
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
57.6 percentage of participants
Interval 39.22 to 74.52
|
65.7 percentage of participants
Interval 47.79 to 80.87
|
61.8 percentage of participants
Interval 49.18 to 73.29
|
SECONDARY outcome
Timeframe: Week 52Population: Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those participants with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Mucosal healing per Mayo endoscopy subscore is defined as a subscore of ≤ 1.
Outcome measures
| Measure |
Main Study: I-SD
n=12 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-HD
n=31 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-SD + I-HD
n=31 Participants
Combined I-SD + I-HD arms (see above).
|
Main Study: I-HD-OL
n=62 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD
n=12 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-HD
n=33 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
n=35 Participants
Combined I-SD + I-HD arms (see above).
|
Integrated Study (Main + Japan Sub-Study): I-HD-OL
n=68 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
|---|---|---|---|---|---|---|---|---|
|
Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
38.7 percentage of participants
Interval 21.85 to 57.81
|
51.6 percentage of participants
Interval 33.06 to 69.85
|
45.2 percentage of participants
Interval 32.48 to 58.32
|
33.3 percentage of participants
Interval 9.92 to 65.11
|
36.4 percentage of participants
Interval 20.4 to 54.88
|
48.6 percentage of participants
Interval 31.38 to 66.01
|
42.6 percentage of participants
Interval 30.72 to 55.23
|
SECONDARY outcome
Timeframe: Week 52Population: Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. Participants who were also Week 8 remitters. NRI: missing data is imputed as not having met the endpoint.
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS remitters are defined as those participants with a PMS ≤ 2 and no individual subscore \> 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Outcome measures
| Measure |
Main Study: I-SD
n=8 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-HD
n=21 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-SD + I-HD
n=22 Participants
Combined I-SD + I-HD arms (see above).
|
Main Study: I-HD-OL
n=43 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD
n=8 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-HD
n=21 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
n=25 Participants
Combined I-SD + I-HD arms (see above).
|
Integrated Study (Main + Japan Sub-Study): I-HD-OL
n=46 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
|---|---|---|---|---|---|---|---|---|
|
Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period
|
37.5 percentage of participants
Interval 8.52 to 75.51
|
42.9 percentage of participants
Interval 21.82 to 65.98
|
45.5 percentage of participants
Interval 24.39 to 67.79
|
44.2 percentage of participants
Interval 29.08 to 60.12
|
37.5 percentage of participants
Interval 8.52 to 75.51
|
42.9 percentage of participants
Interval 21.82 to 65.98
|
44.0 percentage of participants
Interval 24.4 to 65.07
|
43.5 percentage of participants
Interval 28.93 to 58.89
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. Participants receiving systemic corticosteroids at baseline. NRI: missing data is imputed as not having met the endpoint.
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore \> 1).
Outcome measures
| Measure |
Main Study: I-SD
n=5 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-HD
n=13 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Main Study: I-SD + I-HD
n=16 Participants
Combined I-SD + I-HD arms (see above).
|
Main Study: I-HD-OL
n=29 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD
n=5 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-HD
n=15 Participants
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
n=17 Participants
Combined I-SD + I-HD arms (see above).
|
Integrated Study (Main + Japan Sub-Study): I-HD-OL
n=32 Participants
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
|
|---|---|---|---|---|---|---|---|---|
|
Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
|
40.0 percentage of participants
Interval 5.27 to 85.34
|
30.8 percentage of participants
Interval 9.09 to 61.43
|
31.3 percentage of participants
Interval 11.02 to 58.66
|
31.0 percentage of participants
Interval 15.28 to 50.83
|
40.0 percentage of participants
Interval 5.27 to 85.34
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
35.3 percentage of participants
Interval 14.21 to 61.67
|
31.3 percentage of participants
Interval 16.12 to 50.01
|
Adverse Events
Integrated Study (Main + Japan Sub- Study): I-SD
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Integrated Study (Main + Japan Sub- Study): I-HD
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Integrated Study (Main + Japan Sub- Study): I-HD-OL
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Integrated Study (Main + Japan Sub- Study): M-SD
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Integrated Study (Main + Japan Sub- Study): M-HD
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Integrated Study (Main + Japan Sub- Study): M-PL
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Integrated Study (Main + Japan Sub- Study): Any Adalimumab
Serious events: 22 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Integrated Study (Main + Japan Sub- Study): I-SD
n=32 participants at risk
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 52.8 days.
|
Integrated Study (Main + Japan Sub- Study): I-HD
n=51 participants at risk
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.4 days.
|
Integrated Study (Main + Japan Sub- Study): I-HD-OL
n=18 participants at risk
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 53.8 days.
|
Integrated Study (Main + Japan Sub- Study): M-SD
n=33 participants at risk
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 226.8 days.
|
Integrated Study (Main + Japan Sub- Study): M-HD
n=36 participants at risk
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 241.0 days.
|
Integrated Study (Main + Japan Sub- Study): M-PL
n=12 participants at risk
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 184.2 days.
|
Integrated Study (Main + Japan Sub- Study): Any Adalimumab
n=101 participants at risk
Participants receiving any adalimumab during Induction or Maintenance Phase.
Any Adalimumab TEAEs: events with an onset date on or after first dose date of adalimumab and up to 70 days after the last dose date of adalimumab and prior to the first dose date in M10-870 if applicable, whichever comes first. For participants who received placebo during the maintenance period, TEAE collection period ends 70 days after last induction dose of adalimumab and re-starts with their next adalimumab dose, if applicable. Mean duration of treatment was 256.3 days.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.2%
2/32 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
3/101 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Cardiac disorders
PERICARDITIS
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
6.2%
2/32 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.9%
2/51 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.1%
3/33 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.9%
10/101 • Number of events 11 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
ENTERITIS INFECTIOUS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.1%
2/33 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Nervous system disorders
HEADACHE
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/101 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
Other adverse events
| Measure |
Integrated Study (Main + Japan Sub- Study): I-SD
n=32 participants at risk
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 52.8 days.
|
Integrated Study (Main + Japan Sub- Study): I-HD
n=51 participants at risk
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.4 days.
|
Integrated Study (Main + Japan Sub- Study): I-HD-OL
n=18 participants at risk
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 53.8 days.
|
Integrated Study (Main + Japan Sub- Study): M-SD
n=33 participants at risk
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 226.8 days.
|
Integrated Study (Main + Japan Sub- Study): M-HD
n=36 participants at risk
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 241.0 days.
|
Integrated Study (Main + Japan Sub- Study): M-PL
n=12 participants at risk
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 184.2 days.
|
Integrated Study (Main + Japan Sub- Study): Any Adalimumab
n=101 participants at risk
Participants receiving any adalimumab during Induction or Maintenance Phase.
Any Adalimumab TEAEs: events with an onset date on or after first dose date of adalimumab and up to 70 days after the last dose date of adalimumab and prior to the first dose date in M10-870 if applicable, whichever comes first. For participants who received placebo during the maintenance period, TEAE collection period ends 70 days after last induction dose of adalimumab and re-starts with their next adalimumab dose, if applicable. Mean duration of treatment was 256.3 days.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.9%
3/51 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.1%
2/33 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.9%
9/101 • Number of events 9 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/101 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Eye disorders
NONINFECTIVE CONJUNCTIVITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.9%
2/51 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
11.1%
2/18 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.9%
6/101 • Number of events 11 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.9%
2/51 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
2/36 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
4.0%
4/101 • Number of events 5 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
6.2%
2/32 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.1%
3/33 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
11.1%
4/36 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
16.7%
2/12 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
10.9%
11/101 • Number of events 14 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.9%
3/51 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
4.0%
4/101 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
3/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
General disorders
FATIGUE
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.1%
2/33 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
3/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
General disorders
INFLAMMATION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
General disorders
PERIPHERAL SWELLING
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
General disorders
PYREXIA
|
6.2%
2/32 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.0%
5/101 • Number of events 5 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
2/36 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
2/32 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.9%
2/51 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.1%
3/33 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
11.1%
4/36 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
11.9%
12/101 • Number of events 18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
PHARYNGITIS
|
6.2%
2/32 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.1%
2/33 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.9%
9/101 • Number of events 10 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
STREPTOCOCCAL INFECTION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.9%
3/51 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.1%
2/33 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
11.1%
4/36 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
16.7%
2/12 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.9%
10/101 • Number of events 13 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/101 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.1%
3/33 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.0%
5/101 • Number of events 5 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Investigations
MONOCYTE COUNT DECREASED
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
3/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/101 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Nervous system disorders
HEADACHE
|
12.5%
4/32 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
9.8%
5/51 • Number of events 7 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
22.2%
4/18 • Number of events 6 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
18.2%
6/33 • Number of events 6 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
2/36 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
16.7%
2/12 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
18.8%
19/101 • Number of events 28 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Renal and urinary disorders
GLYCOSURIA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
2/36 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
4.0%
4/101 • Number of events 6 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
16.7%
2/12 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.1%
1/32 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
11.1%
2/18 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.1%
2/33 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
6.9%
7/101 • Number of events 8 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
2/36 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
1/51 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
3/101 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.8%
1/36 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
2.0%
2/101 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Skin and subcutaneous tissue disorders
HANGNAIL
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/18 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/33 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/36 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
8.3%
1/12 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.99%
1/101 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/32 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/51 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
1/18 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
3.0%
1/33 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
5.6%
2/36 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
0.00%
0/12 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
4.0%
4/101 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below.
Treatment-emergent adverse events (TEAEs) are presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER