Trial Outcomes & Findings for An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis (NCT NCT02497469)
NCT ID: NCT02497469
Last Updated: 2020-01-28
Results Overview
Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore \>1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
771 participants
Primary outcome timeframe
Week 52
Results posted on
2020-01-28
Participant Flow
Participants took part in the study at 205 investigative sites worldwide from 29 June 2015 up to 18 January 2019.
Participants with a diagnosis of moderately to severely active ulcerative colitis (UC) were enrolled in a 1:1 ratio to receive vedolizumab or adalimumab and matching placebo.
Participant milestones
| Measure |
Adalimumab SC, 160/80/40 mg
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Overall Study
STARTED
|
386
|
385
|
|
Overall Study
Safety Analysis Set
|
386
|
383
|
|
Overall Study
COMPLETED
|
217
|
270
|
|
Overall Study
NOT COMPLETED
|
169
|
115
|
Reasons for withdrawal
| Measure |
Adalimumab SC, 160/80/40 mg
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Overall Study
Randomized but not Treated
|
0
|
2
|
|
Overall Study
Pretreatment Event/Adverse Event
|
18
|
16
|
|
Overall Study
Leukopenia or Lymphopenia
|
1
|
0
|
|
Overall Study
Significant Protocol Deviation
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
14
|
4
|
|
Overall Study
Voluntary Withdrawal
|
39
|
41
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
86
|
40
|
|
Overall Study
Reason not Specified
|
6
|
6
|
Baseline Characteristics
Number analyzed are participants with data available for height.
Baseline characteristics by cohort
| Measure |
Adalimumab SC, 160/80/40 mg
n=386 Participants
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
n=385 Participants
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
Total
n=771 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 13.44 • n=386 Participants
|
40.8 years
STANDARD_DEVIATION 13.74 • n=385 Participants
|
40.7 years
STANDARD_DEVIATION 13.59 • n=771 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=386 Participants
|
151 Participants
n=385 Participants
|
321 Participants
n=771 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=386 Participants
|
234 Participants
n=385 Participants
|
450 Participants
n=771 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=386 Participants
|
8 Participants
n=385 Participants
|
14 Participants
n=771 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=386 Participants
|
23 Participants
n=385 Participants
|
62 Participants
n=771 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
341 Participants
n=386 Participants
|
354 Participants
n=385 Participants
|
695 Participants
n=771 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=386 Participants
|
4 Participants
n=385 Participants
|
15 Participants
n=771 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=386 Participants
|
32 Participants
n=385 Participants
|
62 Participants
n=771 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=386 Participants
|
0 Participants
n=385 Participants
|
1 Participants
n=771 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=386 Participants
|
2 Participants
n=385 Participants
|
5 Participants
n=771 Participants
|
|
Race (NIH/OMB)
White
|
341 Participants
n=386 Participants
|
345 Participants
n=385 Participants
|
686 Participants
n=771 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=386 Participants
|
2 Participants
n=385 Participants
|
2 Participants
n=771 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=386 Participants
|
0 Participants
n=385 Participants
|
0 Participants
n=771 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=386 Participants
|
5 Participants
n=385 Participants
|
8 Participants
n=771 Participants
|
|
Region of Enrollment
Hong Kong
|
1 Participants
n=386 Participants
|
4 Participants
n=385 Participants
|
5 Participants
n=771 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
19 Participants
n=386 Participants
|
16 Participants
n=385 Participants
|
35 Participants
n=771 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
4 Participants
n=386 Participants
|
1 Participants
n=385 Participants
|
5 Participants
n=771 Participants
|
|
Region of Enrollment
Czech Republic
|
13 Participants
n=386 Participants
|
8 Participants
n=385 Participants
|
21 Participants
n=771 Participants
|
|
Region of Enrollment
Hungary
|
16 Participants
n=386 Participants
|
16 Participants
n=385 Participants
|
32 Participants
n=771 Participants
|
|
Region of Enrollment
Poland
|
78 Participants
n=386 Participants
|
85 Participants
n=385 Participants
|
163 Participants
n=771 Participants
|
|
Region of Enrollment
Serbia
|
11 Participants
n=386 Participants
|
18 Participants
n=385 Participants
|
29 Participants
n=771 Participants
|
|
Region of Enrollment
Slovakia
|
5 Participants
n=386 Participants
|
8 Participants
n=385 Participants
|
13 Participants
n=771 Participants
|
|
Region of Enrollment
Bosnia
|
2 Participants
n=386 Participants
|
1 Participants
n=385 Participants
|
3 Participants
n=771 Participants
|
|
Region of Enrollment
Bulgaria
|
10 Participants
n=386 Participants
|
6 Participants
n=385 Participants
|
16 Participants
n=771 Participants
|
|
Region of Enrollment
Croatia
|
11 Participants
n=386 Participants
|
5 Participants
n=385 Participants
|
16 Participants
n=771 Participants
|
|
Region of Enrollment
Israel
|
9 Participants
n=386 Participants
|
13 Participants
n=385 Participants
|
22 Participants
n=771 Participants
|
|
Region of Enrollment
Romania
|
6 Participants
n=386 Participants
|
6 Participants
n=385 Participants
|
12 Participants
n=771 Participants
|
|
Region of Enrollment
Russia
|
41 Participants
n=386 Participants
|
44 Participants
n=385 Participants
|
85 Participants
n=771 Participants
|
|
Region of Enrollment
Turkey
|
9 Participants
n=386 Participants
|
5 Participants
n=385 Participants
|
14 Participants
n=771 Participants
|
|
Region of Enrollment
Ukraine
|
26 Participants
n=386 Participants
|
39 Participants
n=385 Participants
|
65 Participants
n=771 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=386 Participants
|
20 Participants
n=385 Participants
|
38 Participants
n=771 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=386 Participants
|
29 Participants
n=385 Participants
|
71 Participants
n=771 Participants
|
|
Region of Enrollment
Argentina
|
1 Participants
n=386 Participants
|
3 Participants
n=385 Participants
|
4 Participants
n=771 Participants
|
|
Region of Enrollment
Colombia
|
2 Participants
n=386 Participants
|
2 Participants
n=385 Participants
|
4 Participants
n=771 Participants
|
|
Region of Enrollment
Mexico
|
9 Participants
n=386 Participants
|
3 Participants
n=385 Participants
|
12 Participants
n=771 Participants
|
|
Region of Enrollment
France
|
4 Participants
n=386 Participants
|
6 Participants
n=385 Participants
|
10 Participants
n=771 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=386 Participants
|
6 Participants
n=385 Participants
|
9 Participants
n=771 Participants
|
|
Region of Enrollment
Italy
|
9 Participants
n=386 Participants
|
11 Participants
n=385 Participants
|
20 Participants
n=771 Participants
|
|
Region of Enrollment
Latvia
|
6 Participants
n=386 Participants
|
7 Participants
n=385 Participants
|
13 Participants
n=771 Participants
|
|
Region of Enrollment
Lithuania
|
7 Participants
n=386 Participants
|
7 Participants
n=385 Participants
|
14 Participants
n=771 Participants
|
|
Region of Enrollment
Portugal
|
9 Participants
n=386 Participants
|
4 Participants
n=385 Participants
|
13 Participants
n=771 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=386 Participants
|
3 Participants
n=385 Participants
|
5 Participants
n=771 Participants
|
|
Region of Enrollment
Denmark
|
8 Participants
n=386 Participants
|
3 Participants
n=385 Participants
|
11 Participants
n=771 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=386 Participants
|
1 Participants
n=385 Participants
|
1 Participants
n=771 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=386 Participants
|
0 Participants
n=385 Participants
|
1 Participants
n=771 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=386 Participants
|
0 Participants
n=385 Participants
|
1 Participants
n=771 Participants
|
|
Height
|
170.5 cm
STANDARD_DEVIATION 9.65 • n=386 Participants • Number analyzed are participants with data available for height.
|
172.0 cm
STANDARD_DEVIATION 9.90 • n=383 Participants • Number analyzed are participants with data available for height.
|
171.3 cm
STANDARD_DEVIATION 9.79 • n=769 Participants • Number analyzed are participants with data available for height.
|
|
Weight
|
73.43 kg
STANDARD_DEVIATION 18.374 • n=386 Participants • Number analyzed are participants with data available for weight.
|
72.67 kg
STANDARD_DEVIATION 16.952 • n=383 Participants • Number analyzed are participants with data available for weight.
|
73.05 kg
STANDARD_DEVIATION 17.673 • n=769 Participants • Number analyzed are participants with data available for weight.
|
|
Body Mass Index (BMI)
|
25.17 kg/m^2
STANDARD_DEVIATION 5.646 • n=386 Participants • Number analyzed are participants with data available for BMI.
|
24.46 kg/m^2
STANDARD_DEVIATION 4.786 • n=383 Participants • Number analyzed are participants with data available for BMI.
|
24.82 kg/m^2
STANDARD_DEVIATION 5.244 • n=769 Participants • Number analyzed are participants with data available for BMI.
|
|
Smoking Classification
Has Never Smoked
|
259 Participants
n=386 Participants
|
280 Participants
n=385 Participants
|
539 Participants
n=771 Participants
|
|
Smoking Classification
Is a Current Smoker
|
23 Participants
n=386 Participants
|
19 Participants
n=385 Participants
|
42 Participants
n=771 Participants
|
|
Smoking Classification
Is an Ex-smoker
|
104 Participants
n=386 Participants
|
84 Participants
n=385 Participants
|
188 Participants
n=771 Participants
|
|
Smoking Classification
Missing
|
0 Participants
n=386 Participants
|
2 Participants
n=385 Participants
|
2 Participants
n=771 Participants
|
|
Female Reproductive Status
Postmenopausal
|
29 Participants
n=170 Participants • Number analyzed are female participants.
|
32 Participants
n=151 Participants • Number analyzed are female participants.
|
61 Participants
n=321 Participants • Number analyzed are female participants.
|
|
Female Reproductive Status
Surgically Sterile
|
18 Participants
n=170 Participants • Number analyzed are female participants.
|
17 Participants
n=151 Participants • Number analyzed are female participants.
|
35 Participants
n=321 Participants • Number analyzed are female participants.
|
|
Female Reproductive Status
Female of Childbearing Potential
|
123 Participants
n=170 Participants • Number analyzed are female participants.
|
102 Participants
n=151 Participants • Number analyzed are female participants.
|
225 Participants
n=321 Participants • Number analyzed are female participants.
|
PRIMARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore \>1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Outcome measures
| Measure |
Adalimumab SC, 160/80/40 mg
n=386 Participants
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
n=383 Participants
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission
|
22.5 percentage of participants
Interval 18.5 to 27.0
|
31.3 percentage of participants
Interval 26.7 to 36.2
|
SECONDARY outcome
Timeframe: Week 52Population: FAS included all randomized participants who received at least 1 dose of study drug.
Mucosal healing was defined as a Mayo score endoscopic subscore of \<= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Outcome measures
| Measure |
Adalimumab SC, 160/80/40 mg
n=386 Participants
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
n=383 Participants
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Percentage of Participants Who Achieved Mucosal Healing
|
27.7 percentage of participants
Interval 23.3 to 32.5
|
39.7 percentage of participants
Interval 34.8 to 44.8
|
SECONDARY outcome
Timeframe: Week 52Population: Particiopants from, FAS, included all randomized participants who received at least 1 dose of study drug who used who used oral corticosteroids at Baseline.
Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of ≤ 2 points and no individual subscore \> 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Outcome measures
| Measure |
Adalimumab SC, 160/80/40 mg
n=119 Participants
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
n=111 Participants
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
|
21.8 percentage of participants
Interval 14.8 to 30.4
|
12.6 percentage of participants
Interval 7.1 to 20.3
|
Adverse Events
Adalimumab SC, 160/80/40 mg
Serious events: 53 serious events
Other events: 114 other events
Deaths: 0 deaths
Vedolizumab IV 300 mg
Serious events: 42 serious events
Other events: 103 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Adalimumab SC, 160/80/40 mg
n=386 participants at risk
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
n=383 participants at risk
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Nervous system disorders
Dysgraphia
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.52%
2/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Vascular disorders
Hypovolaemic shock
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
4/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Eye disorders
Blindness
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
6.5%
25/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
5.0%
19/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Colitis
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.52%
2/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.78%
3/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
General disorders
Therapeutic response decreased
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Appendicitis
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Anal abscess
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.78%
3/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Liver abscess
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Varicella
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Wound infection
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Pneumonia
|
0.52%
2/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Gamma-glutamyltransferase increased
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.52%
2/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.26%
1/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
0.00%
0/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
Other adverse events
| Measure |
Adalimumab SC, 160/80/40 mg
n=386 participants at risk
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
|
Vedolizumab IV 300 mg
n=383 participants at risk
Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
10.9%
42/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
6.8%
26/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
30/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
7.0%
27/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
23/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
5.0%
19/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
17/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
5.2%
20/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
|
Nervous system disorders
Headache
|
5.4%
21/386 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
7.0%
27/383 • From first dose of study drug and up to 126 days after the last dose (Up to 68 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER