Trial Outcomes & Findings for Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (NCT NCT00783692)
NCT ID: NCT00783692
Last Updated: 2014-07-21
Results Overview
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1116 participants
Primary outcome timeframe
Week 6
Results posted on
2014-07-21
Participant Flow
Participants took part in the study at 285 investigative sites worldwide from 23 December 2008 to 08 May 2012. The Induction Phase contained 2 cohorts. The eligibility criteria for both cohorts were identical. The purpose of Cohort 2 was to provide enough responders to power the Maintenance Phase primary efficacy analysis.
In Cohort 1, eligible patients who met entry criteria were randomized to treatment with double-blind vedolizumab 300 mg or placebo in a 3:2 ratio. All Cohort 2 patients were treated with open-label vedolizumab. In the Maintenance Phase participants were assigned to treatment groups based on their Induction Phase treatment and response to therapy.
Participant milestones
| Measure |
Placebo
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
|
Induction Phase: DB Vedolizumab
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
|
Induction Phase: OL Vedolizumab
In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
|
Maintenance Phase: Placebo
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
|
Maintenance Phase: Vedolizumab Q8W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
|
Maintenance Phase: Vedolizumab Q4W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
Maintenance Phase: Non-Responders
Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
|
|---|---|---|---|---|---|---|---|
|
Induction Phase
STARTED
|
148
|
220
|
748
|
0
|
0
|
0
|
0
|
|
Induction Phase
Treated
|
148
|
220
|
747
|
0
|
0
|
0
|
0
|
|
Induction Phase
COMPLETED
|
137
|
199
|
674
|
0
|
0
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
11
|
21
|
74
|
0
|
0
|
0
|
0
|
|
Maintenance Phase
STARTED
|
137
|
0
|
0
|
153
|
154
|
154
|
412
|
|
Maintenance Phase
COMPLETED
|
42
|
0
|
0
|
64
|
73
|
82
|
163
|
|
Maintenance Phase
NOT COMPLETED
|
95
|
0
|
0
|
89
|
81
|
72
|
249
|
Reasons for withdrawal
| Measure |
Placebo
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
|
Induction Phase: DB Vedolizumab
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
|
Induction Phase: OL Vedolizumab
In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
|
Maintenance Phase: Placebo
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
|
Maintenance Phase: Vedolizumab Q8W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
|
Maintenance Phase: Vedolizumab Q4W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
Maintenance Phase: Non-Responders
Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
|
|---|---|---|---|---|---|---|---|
|
Induction Phase
Adverse Event
|
7
|
9
|
24
|
0
|
0
|
0
|
0
|
|
Induction Phase
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Induction Phase
Lack of Efficacy
|
1
|
3
|
28
|
0
|
0
|
0
|
0
|
|
Induction Phase
Withdrawal by Subject
|
3
|
9
|
16
|
0
|
0
|
0
|
0
|
|
Induction Phase
Lost to Follow-up
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Induction Phase
Other
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Maintenance Phase
Adverse Event
|
7
|
0
|
0
|
15
|
12
|
9
|
38
|
|
Maintenance Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
2
|
3
|
4
|
|
Maintenance Phase
Lack of Efficacy
|
79
|
0
|
0
|
64
|
58
|
48
|
177
|
|
Maintenance Phase
Withdrawal by Subject
|
7
|
0
|
0
|
7
|
6
|
9
|
24
|
|
Maintenance Phase
Lost to Follow-up
|
2
|
0
|
0
|
1
|
3
|
2
|
5
|
|
Maintenance Phase
Other
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=148 Participants
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2.
|
Induction Phase: DB Vedolizumab
n=220 Participants
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
|
Induction Phase: OL Vedolizumab
n=747 Participants
In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
|
Total
n=1115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
Turkey
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
Ukraine
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 13.16 • n=99 Participants
|
36.3 years
STANDARD_DEVIATION 11.57 • n=107 Participants
|
35.6 years
STANDARD_DEVIATION 12.01 • n=206 Participants
|
36.1 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
|
Age, Customized
< 35 years
|
67 participants
n=99 Participants
|
111 participants
n=107 Participants
|
404 participants
n=206 Participants
|
582 participants
n=7 Participants
|
|
Age, Customized
≥ 35 years
|
81 participants
n=99 Participants
|
109 participants
n=107 Participants
|
343 participants
n=206 Participants
|
533 participants
n=7 Participants
|
|
Age, Customized
< 65 years
|
142 participants
n=99 Participants
|
218 participants
n=107 Participants
|
732 participants
n=206 Participants
|
1092 participants
n=7 Participants
|
|
Age, Customized
≥ 65 years
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
15 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
401 Participants
n=206 Participants
|
595 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
346 Participants
n=206 Participants
|
520 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
712 Participants
n=206 Participants
|
1065 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
124 participants
n=99 Participants
|
182 participants
n=107 Participants
|
689 participants
n=206 Participants
|
995 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
17 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 participants
n=99 Participants
|
35 participants
n=107 Participants
|
35 participants
n=206 Participants
|
89 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=99 Participants
|
10 participants
n=107 Participants
|
30 participants
n=206 Participants
|
45 participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=99 Participants
|
17 participants
n=107 Participants
|
41 participants
n=206 Participants
|
70 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
Bulgaria
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
2 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=99 Participants
|
12 participants
n=107 Participants
|
103 participants
n=206 Participants
|
137 participants
n=7 Participants
|
|
Region of Enrollment
Czech Republic
|
11 participants
n=99 Participants
|
16 participants
n=107 Participants
|
53 participants
n=206 Participants
|
80 participants
n=7 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Region of Enrollment
Estonia
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
France
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
37 participants
n=206 Participants
|
44 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
49 participants
n=206 Participants
|
50 participants
n=7 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Hong Kong
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
9 participants
n=99 Participants
|
17 participants
n=107 Participants
|
47 participants
n=206 Participants
|
73 participants
n=7 Participants
|
|
Region of Enrollment
Iceland
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
India
|
10 participants
n=99 Participants
|
19 participants
n=107 Participants
|
5 participants
n=206 Participants
|
34 participants
n=7 Participants
|
|
Region of Enrollment
Ireland
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
13 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Region of Enrollment
Korea, Republic of
|
3 participants
n=99 Participants
|
12 participants
n=107 Participants
|
11 participants
n=206 Participants
|
26 participants
n=7 Participants
|
|
Region of Enrollment
Latvia
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Region of Enrollment
New Zealand
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
3 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Region of Enrollment
Norway
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
13 participants
n=206 Participants
|
13 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
27 participants
n=7 Participants
|
|
Region of Enrollment
Romania
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
Russian Federation
|
4 participants
n=99 Participants
|
9 participants
n=107 Participants
|
15 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
Singapore
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Slovakia
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Region of Enrollment
South Africa
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
14 participants
n=206 Participants
|
20 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
8 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
9 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
52 participants
n=107 Participants
|
188 participants
n=206 Participants
|
268 participants
n=7 Participants
|
|
Body Weight
|
68.7 kg
STANDARD_DEVIATION 18.90 • n=99 Participants
|
67.1 kg
STANDARD_DEVIATION 19.07 • n=107 Participants
|
70.8 kg
STANDARD_DEVIATION 19.56 • n=206 Participants
|
69.8 kg
STANDARD_DEVIATION 19.42 • n=7 Participants
|
|
Body Mass Index (BMI)
|
23.7 kg/m^2
STANDARD_DEVIATION 5.77 • n=99 Participants
|
23.1 kg/m^2
STANDARD_DEVIATION 5.62 • n=107 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 6.02 • n=206 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 5.93 • n=7 Participants
|
|
Duration of Crohn's Disease (CD)
|
8.2 years
STANDARD_DEVIATION 7.80 • n=99 Participants
|
9.2 years
STANDARD_DEVIATION 8.18 • n=107 Participants
|
9.2 years
STANDARD_DEVIATION 7.63 • n=206 Participants
|
9.0 years
STANDARD_DEVIATION 7.77 • n=7 Participants
|
|
Duration of Crohn's Disease - Categorical
< 1 year
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
45 participants
n=206 Participants
|
69 participants
n=7 Participants
|
|
Duration of Crohn's Disease - Categorical
≥ 1 to < 3 years
|
27 participants
n=99 Participants
|
48 participants
n=107 Participants
|
126 participants
n=206 Participants
|
201 participants
n=7 Participants
|
|
Duration of Crohn's Disease - Categorical
≥ 3 to < 7 years
|
45 participants
n=99 Participants
|
49 participants
n=107 Participants
|
191 participants
n=206 Participants
|
285 participants
n=7 Participants
|
|
Duration of Crohn's Disease - Categorical
≥ 7 years
|
64 participants
n=99 Participants
|
111 participants
n=107 Participants
|
385 participants
n=206 Participants
|
560 participants
n=7 Participants
|
|
Baseline Disease Activity - Crohn's Disease Activity Index (CDAI)
|
324.6 units on a scale
STANDARD_DEVIATION 78.08 • n=99 Participants
|
327.3 units on a scale
STANDARD_DEVIATION 70.67 • n=107 Participants
|
322.2 units on a scale
STANDARD_DEVIATION 67.17 • n=206 Participants
|
323.6 units on a scale
STANDARD_DEVIATION 69.37 • n=7 Participants
|
|
Baseline Disease Activity - Categorical
CDAI ≤ 330
|
81 participants
n=99 Participants
|
119 participants
n=107 Participants
|
418 participants
n=206 Participants
|
618 participants
n=7 Participants
|
|
Baseline Disease Activity - Categorical
CDAI > 330
|
66 participants
n=99 Participants
|
100 participants
n=107 Participants
|
325 participants
n=206 Participants
|
491 participants
n=7 Participants
|
|
Baseline Disease Activity - Categorical
Missing
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Baseline C-reactive Protein (CRP)
|
23.6 mg/L
STANDARD_DEVIATION 27.85 • n=99 Participants
|
24.1 mg/L
STANDARD_DEVIATION 27.23 • n=107 Participants
|
20.4 mg/L
STANDARD_DEVIATION 27.40 • n=206 Participants
|
21.5 mg/L
STANDARD_DEVIATION 27.45 • n=7 Participants
|
|
Baseline CRP - Categorical
≤ 2.87 mg/L
|
20 participants
n=99 Participants
|
37 participants
n=107 Participants
|
130 participants
n=206 Participants
|
187 participants
n=7 Participants
|
|
Baseline CRP - Categorical
> 2.87 to ≤ 5 mg/L
|
14 participants
n=99 Participants
|
25 participants
n=107 Participants
|
75 participants
n=206 Participants
|
114 participants
n=7 Participants
|
|
Baseline CRP - Categorical
> 5 to ≤ 10 mg/L
|
28 participants
n=99 Participants
|
38 participants
n=107 Participants
|
160 participants
n=206 Participants
|
226 participants
n=7 Participants
|
|
Baseline CRP - Categorical
> 10 mg/L
|
85 participants
n=99 Participants
|
120 participants
n=107 Participants
|
382 participants
n=206 Participants
|
587 participants
n=7 Participants
|
|
Baseline CRP - Categorical
Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Baseline Fecal Calprotectin
|
1421.2 μg/g
STANDARD_DEVIATION 2076.11 • n=99 Participants
|
1839.9 μg/g
STANDARD_DEVIATION 2624.92 • n=107 Participants
|
1050.1 μg/g
STANDARD_DEVIATION 1558.93 • n=206 Participants
|
1254.2 μg/g
STANDARD_DEVIATION 1908.82 • n=7 Participants
|
|
Baseline Fecal Calprotectin - Categorical
≤ 250 μg/g
|
34 participants
n=99 Participants
|
51 participants
n=107 Participants
|
201 participants
n=206 Participants
|
286 participants
n=7 Participants
|
|
Baseline Fecal Calprotectin - Categorical
> 250 to ≤ 500 μg/g
|
27 participants
n=99 Participants
|
25 participants
n=107 Participants
|
112 participants
n=206 Participants
|
164 participants
n=7 Participants
|
|
Baseline Fecal Calprotectin - Categorical
> 500 μg/g
|
81 participants
n=99 Participants
|
134 participants
n=107 Participants
|
406 participants
n=206 Participants
|
621 participants
n=7 Participants
|
|
Baseline Fecal Calprotectin - Categorical
Missing
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
28 participants
n=206 Participants
|
44 participants
n=7 Participants
|
|
Disease Localization
Ileum only
|
21 participants
n=99 Participants
|
37 participants
n=107 Participants
|
123 participants
n=206 Participants
|
181 participants
n=7 Participants
|
|
Disease Localization
Colon only
|
43 participants
n=99 Participants
|
62 participants
n=107 Participants
|
211 participants
n=206 Participants
|
316 participants
n=7 Participants
|
|
Disease Localization
Ileocolonic (both ileum and colon)
|
84 participants
n=99 Participants
|
121 participants
n=107 Participants
|
413 participants
n=206 Participants
|
618 participants
n=7 Participants
|
|
History of Prior Surgery for Crohn's Disease
Yes
|
54 participants
n=99 Participants
|
98 participants
n=107 Participants
|
314 participants
n=206 Participants
|
466 participants
n=7 Participants
|
|
History of Prior Surgery for Crohn's Disease
No
|
94 participants
n=99 Participants
|
122 participants
n=107 Participants
|
433 participants
n=206 Participants
|
649 participants
n=7 Participants
|
|
History of Fistulizing Disease
Yes
|
56 participants
n=99 Participants
|
90 participants
n=107 Participants
|
264 participants
n=206 Participants
|
410 participants
n=7 Participants
|
|
History of Fistulizing Disease
No
|
92 participants
n=99 Participants
|
130 participants
n=107 Participants
|
483 participants
n=206 Participants
|
705 participants
n=7 Participants
|
|
Draining Fistula at Baseline
Yes
|
23 participants
n=99 Participants
|
38 participants
n=107 Participants
|
104 participants
n=206 Participants
|
165 participants
n=7 Participants
|
|
Draining Fistula at Baseline
All Closed
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
8 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Draining Fistula at Baseline
No
|
123 participants
n=99 Participants
|
181 participants
n=107 Participants
|
635 participants
n=206 Participants
|
939 participants
n=7 Participants
|
|
Smoking Status
Current smoker
|
34 participants
n=99 Participants
|
54 participants
n=107 Participants
|
210 participants
n=206 Participants
|
298 participants
n=7 Participants
|
|
Smoking Status
Nonsmoker (never smoked)
|
85 participants
n=99 Participants
|
120 participants
n=107 Participants
|
351 participants
n=206 Participants
|
556 participants
n=7 Participants
|
|
Smoking Status
Former smoker
|
29 participants
n=99 Participants
|
46 participants
n=107 Participants
|
185 participants
n=206 Participants
|
260 participants
n=7 Participants
|
|
Smoking Status
Missing
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Baseline Extraintestinal Manifestations
Yes
|
107 participants
n=99 Participants
|
133 participants
n=107 Participants
|
456 participants
n=206 Participants
|
696 participants
n=7 Participants
|
|
Baseline Extraintestinal Manifestations
No
|
41 participants
n=99 Participants
|
87 participants
n=107 Participants
|
291 participants
n=206 Participants
|
419 participants
n=7 Participants
|
|
History of Extraintestinal Manifestations
Yes
|
123 participants
n=99 Participants
|
177 participants
n=107 Participants
|
619 participants
n=206 Participants
|
919 participants
n=7 Participants
|
|
History of Extraintestinal Manifestations
No
|
25 participants
n=99 Participants
|
43 participants
n=107 Participants
|
128 participants
n=206 Participants
|
196 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=220 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6
|
6.8 percentage of participants
Interval 2.7 to 10.8
|
14.5 percentage of participants
Interval 9.9 to 19.2
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Induction Study ITT Population
Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=220 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6
|
25.7 percentage of participants
Interval 18.6 to 32.7
|
31.4 percentage of participants
Interval 25.2 to 37.5
|
—
|
PRIMARY outcome
Timeframe: Week 52Population: Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.
Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=154 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
n=154 Participants
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52
|
21.6 percentage of participants
Interval 15.1 to 28.1
|
39.0 percentage of participants
Interval 31.3 to 46.7
|
36.4 percentage of participants
Interval 28.8 to 44.0
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.
C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=220 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6
|
-0.5 mg/L
Interval -27.6 to 12.1
|
-0.9 mg/L
Interval -20.6 to 10.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Maintenance Study ITT Population
Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=154 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
n=154 Participants
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52
|
30.1 percentage of participants
Interval 22.8 to 37.3
|
43.5 percentage of participants
Interval 35.7 to 51.3
|
45.5 percentage of participants
Interval 37.6 to 53.3
|
SECONDARY outcome
Timeframe: Week 52Population: Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.
Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=82 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
n=80 Participants
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52
|
15.9 percentage of participants
Interval 7.9 to 23.8
|
31.7 percentage of participants
Interval 21.6 to 41.8
|
28.8 percentage of participants
Interval 18.8 to 38.7
|
SECONDARY outcome
Timeframe: Assessed every 4 weeks from Week 6 to Week 50, and at Week 52Population: Maintenance Study ITT Population
Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
|
DB Vedolizumab
n=154 Participants
Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
|
Vedolizumab Q4W
n=154 Participants
Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
|
|---|---|---|---|
|
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
|
14.4 percentage of participants
Interval 8.8 to 19.9
|
21.4 percentage of participants
Interval 14.9 to 27.9
|
16.2 percentage of participants
Interval 10.4 to 22.1
|
Adverse Events
Placebo
Serious events: 23 serious events
Other events: 96 other events
Deaths: 0 deaths
VDZ/PBO
Serious events: 23 serious events
Other events: 96 other events
Deaths: 0 deaths
VDZ/VDZ
Serious events: 199 serious events
Other events: 476 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=148 participants at risk
Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
|
VDZ/PBO
n=153 participants at risk
Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
|
VDZ/VDZ
n=814 participants at risk
Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Influenza
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Lung infection
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Device related infection
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Furuncle
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Crohn's disease
|
8.8%
13/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
5.2%
8/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
12.2%
99/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.74%
6/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.49%
4/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
1.3%
2/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.37%
3/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.37%
3/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.37%
3/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
1.3%
2/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Anal fistula
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Anal fissure
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Anal abscess
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
2.0%
16/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
1.3%
2/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.61%
5/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Sepsis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Septic shock
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Bronchopneumonia
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Device related sepsis
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Ureter abscess
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Wound infection
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
General physical health deterioration
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Oedema peripheral
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Pyrexia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Chest discomfort
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Chest pain
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Generalised oedema
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.49%
4/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.37%
3/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.49%
4/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Blood and lymphatic system disorders
Cyclic neutropenia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Psychiatric disorders
Depression
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Psychiatric disorders
Stress
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Vascular disorders
Hypertension
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Vascular disorders
Varicose vein
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Nervous system disorders
Headache
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Eye disorders
Vision blurred
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.25%
2/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Investigations
Weight decreased
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.12%
1/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Investigations
Clostridium test positive
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.65%
1/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.68%
1/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
0.00%
0/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
Other adverse events
| Measure |
Placebo
n=148 participants at risk
Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
|
VDZ/PBO
n=153 participants at risk
Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
|
VDZ/VDZ
n=814 participants at risk
Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.1%
12/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
11.8%
18/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
10.8%
88/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Crohn's disease
|
18.9%
28/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
15.0%
23/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
10.3%
84/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.2%
21/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
11.8%
18/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
9.7%
79/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
10/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
8.5%
13/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
5.9%
48/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
5/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
7.8%
12/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
3.8%
31/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
4/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
5.2%
8/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
2.5%
20/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
10/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
9.2%
14/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
12.3%
100/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
11/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
3.3%
5/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
6.6%
54/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Pyrexia
|
11.5%
17/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
14.4%
22/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
12.5%
102/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
General disorders
Fatigue
|
3.4%
5/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
5.9%
9/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
6.5%
53/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.8%
19/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
13.7%
21/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
13.5%
110/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.1%
9/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
1.3%
2/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
2.8%
23/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Nervous system disorders
Headache
|
12.8%
19/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
18.3%
28/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
11.9%
97/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
9/148 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
3.3%
5/153 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
3.8%
31/814 • From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
|
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