Trial Outcomes & Findings for Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease. (NCT NCT03234907)
NCT ID: NCT03234907
Last Updated: 2023-03-01
Results Overview
Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
215 participants
Primary outcome timeframe
Week 10
Results posted on
2023-03-01
Participant Flow
Participants took part in the study at 27 investigative sites in China from 3 August 2017 to 14 August 2020.
Participants with moderately to severely active Crohn's disease were enrolled and randomized in 2:1 ratio to receive vedolizumab 300 mg or placebo in the Induction Phase of the study. Participants who achieved clinical response at Week 10 entered Maintenance Phase and continued the same study drug, placebo for every 4 weeks and vedolizumab 300 mg for every 8 weeks up to Week 58. Participants who did not achieve response received vedolizumab 300 mg every 4 weeks up to Week 58.
Participant milestones
| Measure |
Induction Phase: Placebo
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Maintenance Phase: Induction Placebo to Placebo Q4W
Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.
|
Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
|---|---|---|---|---|---|---|
|
Induction Phase (Week 0 to Week 10)
STARTED
|
71
|
144
|
0
|
0
|
0
|
0
|
|
Induction Phase (Week 0 to Week 10)
Treated
|
70
|
144
|
0
|
0
|
0
|
0
|
|
Induction Phase (Week 0 to Week 10)
COMPLETED
|
61
|
138
|
0
|
0
|
0
|
0
|
|
Induction Phase (Week 0 to Week 10)
NOT COMPLETED
|
10
|
6
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Week 10 to Week 60)
STARTED
|
0
|
0
|
18
|
38
|
46
|
88
|
|
Maintenance Phase (Week 10 to Week 60)
COMPLETED
|
0
|
0
|
17
|
27
|
36
|
67
|
|
Maintenance Phase (Week 10 to Week 60)
NOT COMPLETED
|
0
|
0
|
1
|
11
|
10
|
21
|
Reasons for withdrawal
| Measure |
Induction Phase: Placebo
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Maintenance Phase: Induction Placebo to Placebo Q4W
Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.
|
Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
|---|---|---|---|---|---|---|
|
Induction Phase (Week 0 to Week 10)
Protocol Deviation
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Induction Phase (Week 0 to Week 10)
Withdrawal by Subject
|
6
|
4
|
0
|
0
|
0
|
0
|
|
Induction Phase (Week 0 to Week 10)
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Induction Phase (Week 0 to Week 10)
Enrolled but not Treated
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Week 10 to Week 60)
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
3
|
7
|
|
Maintenance Phase (Week 10 to Week 60)
Lack of Efficacy
|
0
|
0
|
1
|
3
|
3
|
4
|
|
Maintenance Phase (Week 10 to Week 60)
Reason not Specified
|
0
|
0
|
0
|
4
|
4
|
10
|
Baseline Characteristics
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.
Baseline characteristics by cohort
| Measure |
Induction Phase: Placebo
n=70 Participants
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
n=144 Participants
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
31.1 years
STANDARD_DEVIATION 10.10 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
54.61 kg
STANDARD_DEVIATION 10.662 • n=5 Participants
|
54.33 kg
STANDARD_DEVIATION 10.388 • n=7 Participants
|
54.42 kg
STANDARD_DEVIATION 10.454 • n=5 Participants
|
|
Height
|
168.18 cm
STANDARD_DEVIATION 7.785 • n=5 Participants
|
166.96 cm
STANDARD_DEVIATION 8.064 • n=7 Participants
|
167.36 cm
STANDARD_DEVIATION 7.976 • n=5 Participants
|
|
Body Mass Index (BMI)
|
19.21 kg/m^2
STANDARD_DEVIATION 2.978 • n=5 Participants
|
19.38 kg/m^2
STANDARD_DEVIATION 2.742 • n=7 Participants
|
19.33 kg/m^2
STANDARD_DEVIATION 2.815 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.
Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Outcome measures
| Measure |
Induction Phase: Placebo
n=70 Participants
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
n=144 Participants
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
|---|---|---|
|
Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10
|
24.3 percentage of participants
Interval 14.8 to 36.0
|
19.4 percentage of participants
Interval 13.3 to 26.9
|
SECONDARY outcome
Timeframe: Week 10Population: FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.
Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity
Outcome measures
| Measure |
Induction Phase: Placebo
n=70 Participants
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
n=144 Participants
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
|---|---|---|
|
Percentage of Participants With Clinical Remission in the Induction Phase at Week 10
|
11.4 percentage of participants
Interval 5.1 to 21.3
|
9.0 percentage of participants
Interval 4.9 to 14.9
|
Adverse Events
Induction Phase: Placebo
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Induction Phase: Vedolizumab 300 mg
Serious events: 12 serious events
Other events: 60 other events
Deaths: 0 deaths
Maintenance Phase: Induction Placebo to Placebo Q4W
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
Serious events: 10 serious events
Other events: 23 other events
Deaths: 0 deaths
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
Serious events: 14 serious events
Other events: 27 other events
Deaths: 0 deaths
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
Serious events: 25 serious events
Other events: 63 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Induction Phase: Placebo
n=70 participants at risk
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
n=144 participants at risk
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Maintenance Phase: Induction Placebo to Placebo Q4W
n=18 participants at risk
Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.
|
Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
n=38 participants at risk
Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
n=46 participants at risk
Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
n=88 participants at risk
Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.3%
2/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.69%
1/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.8%
4/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
13.2%
5/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
19.6%
9/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
8.0%
7/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.69%
1/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
1.4%
1/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Intestinal fistula
|
1.4%
1/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.4%
2/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.69%
1/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.69%
1/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.69%
1/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.4%
1/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
1/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.3%
2/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
3.4%
3/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
General disorders
Granuloma
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Anal infection
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Mumps
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Septic shock
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Anal abscess
|
1.4%
1/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.69%
1/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.3%
2/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
Other adverse events
| Measure |
Induction Phase: Placebo
n=70 participants at risk
Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Induction Phase: Vedolizumab 300 mg
n=144 participants at risk
Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
|
Maintenance Phase: Induction Placebo to Placebo Q4W
n=18 participants at risk
Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.
|
Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
n=38 participants at risk
Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
n=46 participants at risk
Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.
|
Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
n=88 participants at risk
Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
10.2%
9/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.1%
2/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
6.8%
6/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
6/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
8/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.1%
2/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
13.0%
6/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.4%
10/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.3%
3/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
6.9%
10/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.3%
2/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.4%
10/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
General disorders
Pyrexia
|
2.9%
2/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
9.0%
13/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
16.7%
3/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
13.0%
6/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
12.5%
11/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Protein urine present
|
7.1%
5/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
9.0%
13/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
7.9%
3/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
8.7%
4/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.4%
10/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.7%
5/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.7%
5/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.3%
2/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
6/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
9.7%
14/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.3%
2/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.4%
10/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
3/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
7.6%
11/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
10.5%
4/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
10.9%
5/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
13.6%
12/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Weight decreased
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
6.5%
3/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.5%
4/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.3%
2/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
3.4%
3/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
6.5%
3/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.3%
2/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.3%
2/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.7%
5/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Blood urine present
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
13.2%
5/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
9.1%
8/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
7/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
8/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
11.1%
2/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
7.9%
3/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
8.7%
4/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
3.4%
3/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.6%
1/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
6.5%
3/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.5%
4/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
16.7%
3/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
2.2%
1/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
8.0%
7/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.6%
1/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
6.5%
3/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
3.4%
3/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/70 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/144 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
0.00%
0/18 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
5.3%
2/38 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
4.3%
2/46 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
1.1%
1/88 • From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)
At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.
|
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